EVICEL Side Effects

7040002-2 |
on Sep 09, 2010 Male patient from UNITED STATES , 78 years of age, weighting 194.0 lb, was diagnosed with vascular operation and was treated with Evicel (View Usage). . Evicel dosage: . During the same period patient was treated with HEPARIN (View Heparin Review and Heparin Label ), ASPIRIN (View Aspirin Review and Aspirin Label ), APPLICATOR (View Applicator Review and Applicator Label ).

7028851-8 | Discomfort, Pain, Post Procedural Haematoma
Patient was taking Evicel (View Usage). Patient had the following side effects: discomfort, pain (What is pain?), post procedural haematoma on Aug 16, 2010 from UNITED STATES Additional patient health information: Male patient , 69 years of age, weighting 171.0 lb, was diagnosed with haemostasis, tissue sealing, face lift and. Evicel dosage: . During the same period patient was treated with APPLICATOR (View Applicator Review and Applicator Label ), PRESSURE REGULATOR (SPRAY (NOT INHALATION)) (Amount Of Pressure Used Was 80 Psi) (View Pressure Regulator (spray (not Inhalation)) Review and Pressure Regulator (spray (not Inhalation)) Label ), KEFLEX (CEFALEXIN) (250 MG) (View Keflex (cefalexin) - (250 Mg) Review and Keflex (cefalexin) - (250 Mg) Label ), ANESTHESIA (ANESTHETICS NOS) (View Anesthesia (anesthetics Nos) Review and Anesthesia (anesthetics Nos) Label ).

7028722-7 | Abdominal Tenderness, Aneurysm, Blood Albumin Decreased, Blood Sodium Decreased, Clostridium Difficile Colitis, Diarrhoea, Fistula, Gastroenteritis, Haematocrit Decreased
Adverse event was reported on Aug 02, 2010 by a Female patient taking Evicel (View Usage) (Dosage: ) was diagnosed with haemostasis and. Location: UNITED STATES , 53 years of age, After Evicel was administered, patient had the following side effects: abdominal tenderness, aneurysm (What is aneurysm?), blood albumin decreased, blood sodium decreased, clostridium difficile colitis, diarrhoea, fistula (What is fistula?), gastroenteritis (What is gastroenteritis?), haematocrit decreased. During the same period patient was treated with PRESSURE REGULATOR (View Pressure Regulator Review and Pressure Regulator Label ), APPLICATOR (View Applicator Review and Applicator Label ), DESYREL (View Desyrel Review and Desyrel Label ), REMERON (View Remeron Review and Remeron Label ), LOPRESSOR (View Lopressor Review and Lopressor Label ), NORVASC (View Norvasc Review and Norvasc Label ), DIOVAN (View Diovan Review and Diovan Label ), PHOSLO CALCIUM (CALCIUM ACETATE) (View Phoslo Calcium (calcium Acetate) Review and Phoslo Calcium (calcium Acetate) Label ). Patient was hospitalized.

7028715-X | Atrioventricular Block Complete, Bradycardia, Cardio-respiratory Arrest, Hypotension, No Therapeutic Response, Pneumonia, Post Procedural Complication, Pulmonary Hypertension, Unresponsive To Stimuli
on Aug 02, 2010 Male patient from UNITED STATES , 70 years of age, weighting 183.0 lb, was diagnosed with vascular operation and was treated with Evicel (View Usage). Patient experienced the following unwanted or unexpected effects: atrioventricular block complete, bradycardia, cardio-respiratory arrest, hypotension, no therapeutic response, pneumonia (What is pneumonia?), post procedural complication, pulmonary hypertension (What is pulmonary hypertension?), unresponsive to stimuli. Evicel dosage: Quantity Used '5cc'. During the same period patient was treated with APPLICATOR (View Applicator Review and Applicator Label ), HEPARIN (View Heparin Review and Heparin Label ), ROCEPHIN (View Rocephin Review and Rocephin Label ), PROPOFOL (View Propofol Review and Propofol Label ), INSULIN (INSULIN) (View Insulin (insulin) Review and Insulin (insulin) Label ), LASIX (View Lasix Review and Lasix Label ).


7028561-7 | Atrioventricular Block Complete, Bradycardia, Cardio-respiratory Arrest, Hypotension, No Therapeutic Response, Pneumonia, Post Procedural Complication, Pulmonary Hypertension, Unresponsive To Stimuli
on Jul 30, 2010 Male patient from UNITED STATES , 70 years of age, weighting 183.0 lb, was diagnosed with fistula (What is fistula?) and was treated with Evicel (View Usage). Patient had the following side effects: atrioventricular block complete, bradycardia, cardio-respiratory arrest, hypotension, no therapeutic response, pneumonia (What is pneumonia?), post procedural complication, pulmonary hypertension (What is pulmonary hypertension?), unresponsive to stimuli. Evicel dosage: Quantity Used '5cc'. During the same period patient was treated with APPLICATOR (View Applicator Review and Applicator Label ), ROCEPHIN (View Rocephin Review and Rocephin Label ), PROPOFOL (View Propofol Review and Propofol Label ), HEPARIN (View Heparin Review and Heparin Label ), INSULIN (INSULIN) (View Insulin (insulin) Review and Insulin (insulin) Label ), LASIX (View Lasix Review and Lasix Label ).

7028555-1 | Arteriovenous Fistula, Blood Albumin Decreased, Blood Pressure Increased, Blood Sodium Decreased, Clostridium Difficile Colitis, Gastroenteritis, Haematocrit Decreased, Haemodialysis
Patient was taking Evicel (View Usage). After Evicel was administered, patient had the following side effects: arteriovenous fistula, blood albumin decreased, blood pressure increased, blood sodium decreased, clostridium difficile colitis, gastroenteritis (What is gastroenteritis?), haematocrit decreased, haemodialysis on Aug 11, 2010 from UNITED STATES Additional patient health information: Female patient , 53 years of age, was diagnosed with haemostasis and. Evicel dosage: . During the same period patient was treated with PRESSURE REGULATOR (Pressure Used Was 5cc) (View Pressure Regulator Review and Pressure Regulator Label ), APPLICATOR (View Applicator Review and Applicator Label ), DESYREL (View Desyrel Review and Desyrel Label ), REMERON (View Remeron Review and Remeron Label ), LOPRESSOR (View Lopressor Review and Lopressor Label ), NORVASC (View Norvasc Review and Norvasc Label ), DIOVAN (View Diovan Review and Diovan Label ), PHOSLO CALCIUM (CALCIUM ACETATE) (View Phoslo Calcium (calcium Acetate) Review and Phoslo Calcium (calcium Acetate) Label ). Patient was hospitalized.

7028492-2 | Off Label Use, Transplant Failure
Adverse event was reported on Aug 03, 2010 by a Female patient taking Evicel (View Usage) (Dosage: ) was diagnosed with pterygium operation and. Location: UNITED STATES , 35 years of age, Patient experienced the following unwanted or unexpected effects: off label use, transplant failure. Patient was hospitalized.

7028474-0 | Septic Shock
on Aug 06, 2010 Female patient from UNITED STATES , 74 years of age, weighting 209.0 lb, was diagnosed with haemostasis and was treated with Evicel (View Usage). Patient had the following side effects: septic shock. Evicel dosage: . During the same period patient was treated with PRESSURE REGULATOR (View Pressure Regulator Review and Pressure Regulator Label ). Patient was hospitalized.

6942605-X | Post Procedural Infection, Staphylococcal Infection
on Jul 28, 2010 Male patient from UNITED STATES , 54 years of age, weighting 339.5 lb, was diagnosed with haemostasis and was treated with Evicel (View Usage). After Evicel was administered, patient had the following side effects: post procedural infection, staphylococcal infection (What is staphylococcal infection?). Evicel dosage: . During the same period patient was treated with PRESSURE REGULATOR (View Pressure Regulator Review and Pressure Regulator Label ), APPLICATOR (View Applicator Review and Applicator Label ). Patient was hospitalized.

6942025-8 | Sepsis
Patient was taking Evicel (View Usage). Patient experienced the following unwanted or unexpected effects: sepsis (What is sepsis?) on Jul 19, 2010 from UNITED STATES Additional patient health information: Female patient , 74 years of age, weighting 209.0 lb, was diagnosed with haemostasis and. Evicel dosage: . During the same period patient was treated with PRESSURE REGULATOR (View Pressure Regulator Review and Pressure Regulator Label ). Patient was hospitalized.

6942005-2 | Atrioventricular Block Complete, Bradycardia, Cardio-respiratory Arrest, Hypotension, Pneumonia, Pulmonary Hypertension
Adverse event was reported on Jul 19, 2010 by a Male patient taking Evicel (View Usage) (Dosage: Quantity Used '5cc') was diagnosed with vascular operation and. Location: UNITED STATES , 70 years of age, weighting 183.0 lb, Patient had the following side effects: atrioventricular block complete, bradycardia, cardio-respiratory arrest, hypotension, pneumonia (What is pneumonia?), pulmonary hypertension (What is pulmonary hypertension?). During the same period patient was treated with HEPARIN (View Heparin Review and Heparin Label ), APPLICATOR (View Applicator Review and Applicator Label ), ROCEPHIN (View Rocephin Review and Rocephin Label ), PROPOFOL (View Propofol Review and Propofol Label ), PRESSURE REGULATOR (View Pressure Regulator Review and Pressure Regulator Label ).

6924411-5 | Haematocrit Decreased, Haemoglobin Decreased, Mean Cell Haemoglobin Concentration Decreased, Mean Cell Haemoglobin Decreased, Nausea, Red Blood Cell Count Decreased
on Jul 19, 2010 Female patient from UNITED STATES , 53 years of age, was diagnosed with haemostasis and was treated with Evicel (View Usage). After Evicel was administered, patient had the following side effects: haematocrit decreased, haemoglobin decreased, mean cell haemoglobin concentration decreased, mean cell haemoglobin decreased, nausea (What is nausea?), red blood cell count decreased. Evicel dosage: . During the same period patient was treated with PRESSURE REGULATOR (View Pressure Regulator Review and Pressure Regulator Label ).

6870159-5 | Bradycardia, Cardiac Arrest, Cardiac Failure Congestive, Hypotension, Pneumonia, Post Procedural Complication, Pulmonary Hypertension, Unresponsive To Stimuli
on Jun 29, 2010 Male patient from UNITED STATES , 70 years of age, was diagnosed with fistula (What is fistula?) and was treated with Evicel (View Usage). Patient experienced the following unwanted or unexpected effects: bradycardia, cardiac arrest (What is cardiac arrest?), cardiac failure congestive, hypotension, pneumonia (What is pneumonia?), post procedural complication, pulmonary hypertension (What is pulmonary hypertension?), unresponsive to stimuli. Evicel dosage: Quantity Used '5cc'. During the same period patient was treated with ROCEPHIN (View Rocephin Review and Rocephin Label ), PROPOFOL (View Propofol Review and Propofol Label ), HEPARIN (View Heparin Review and Heparin Label ).

6831965-6 | Embolic Stroke, Post Procedural Complication, Pulmonary Embolism
Patient was taking Evicel (View Usage). Patient had the following side effects: embolic stroke, post procedural complication, pulmonary embolism (What is pulmonary embolism?) on Apr 07, 2010 from UNITED STATES Additional patient health information: Male patient , 62 years of age, was diagnosed with prostatectomy and. Evicel dosage: Dripped Onto Tissue. During the same period patient was treated with LOVENOX (View Lovenox Review and Lovenox Label ). Patient was hospitalized.

6829288-4 | Haematoma, Haemorrhage, Procedural Site Reaction, Scar, Wound Necrosis
Adverse event was reported on Apr 26, 2010 by a Female patient taking Evicel (View Usage) (Dosage: (250 To 400 Mg As A Single Dose) (sprayed On For A Few Minutes) Epilesional) was diagnosed with haemostasis and. Location: FRANCE , 81 years of age, After Evicel was administered, patient had the following side effects: haematoma, haemorrhage, procedural site reaction, scar (What is scar?), wound necrosis. During the same period patient was treated with PRESSURE REGULATOR DEVICE (View Pressure Regulator Device Review and Pressure Regulator Device Label ), TEMESTA (1 MG) (View Temesta (1 Mg) Review and Temesta (1 Mg) Label ), LACTULOSE (LACTULOSE) (10 G) (View Lactulose (lactulose) (10 G) Review and Lactulose (lactulose) (10 G) Label ), DOLIPRANE (PARACETAMOL) (1 G) (View Doliprane (paracetamol) (1 G) Review and Doliprane (paracetamol) (1 G) Label ), PRADAXA (75 MG) (View Pradaxa (75 Mg) Review and Pradaxa (75 Mg) Label ), OMEPRAZOLE (View Omeprazole Review and Omeprazole Label ), ARESTAL (1 MG) (View Arestal (1 Mg) Review and Arestal (1 Mg) Label ), SMECTA (View Smecta Review and Smecta Label ).

6766924-5 | Erythema, Haematoma, Scar, Skin Necrosis, Wound Haemorrhage, Wound Secretion
on May 04, 2010 Female patient from FRANCE , 81 years of age, was diagnosed with haemostasis and was treated with Evicel (View Usage). Patient experienced the following unwanted or unexpected effects: erythema, haematoma, scar (What is scar?), skin necrosis, wound haemorrhage, wound secretion. Evicel dosage: 250 To 400 Mg As A Single Dose Sprayed On For A Few Minutes. During the same period patient was treated with PRESSURE REGULATOR SERVICE (View Pressure Regulator Service Review and Pressure Regulator Service Label ), LORAZEPAM (View Lorazepam Review and Lorazepam Label ), LACTULOSE (View Lactulose Review and Lactulose Label ), ACETAMINOPHEN (View Acetaminophen Review and Acetaminophen Label ), PRADAXA (View Pradaxa Review and Pradaxa Label ), OMEPRAZOLE (View Omeprazole Review and Omeprazole Label ), LOPERAMIDE HCL (View Loperamide Hcl Review and Loperamide Hcl Label ), SMECTA (View Smecta Review and Smecta Label ).

6766912-9 | Haematoma, Impaired Healing, Scar, Wound Necrosis
on May 11, 2010 Female patient from FRANCE , 81 years of age, was diagnosed with haemostasis and was treated with Evicel (View Usage). Patient had the following side effects: haematoma, impaired healing, scar (What is scar?), wound necrosis. Evicel dosage: 250 To 400 Mg As A Single Dose. During the same period patient was treated with PRESSURE REGULATOR DEVICE (View Pressure Regulator Device Review and Pressure Regulator Device Label ), LORAZEPAM (View Lorazepam Review and Lorazepam Label ), LACTULOSE (View Lactulose Review and Lactulose Label ), ACETAMINOPHEN (View Acetaminophen Review and Acetaminophen Label ), PRADAXA (View Pradaxa Review and Pradaxa Label ), OMEPRAZOLE (View Omeprazole Review and Omeprazole Label ), LOPERAMIDE HCL (View Loperamide Hcl Review and Loperamide Hcl Label ), SMECTA (View Smecta Review and Smecta Label ).

6626826-1 | Embolic Stroke, Post Procedural Complication, Pulmonary Embolism
Patient was taking Evicel (View Usage). After Evicel was administered, patient had the following side effects: embolic stroke, post procedural complication, pulmonary embolism (What is pulmonary embolism?) on Feb 11, 2010 from UNITED STATES Additional patient health information: Male patient , 62 years of age, was diagnosed with prostatectomy and. Evicel dosage: Dripped Onto Tissue. During the same period patient was treated with LOVENOX (View Lovenox Review and Lovenox Label ). Patient was hospitalized.

6607624-1 | Air Embolism, Blood Pressure Decreased, Cardiac Disorder, End-tidal Co2 Decreased, Extrasystoles, Heart Rate Decreased, Medical Device Complication, Oxygen Saturation Decreased, Procedural Complication
Adverse event was reported on Jan 29, 2010 by a Male patient taking Evicel (View Usage) (Dosage: ) was diagnosed with haemostasis, nephrectomy and. Location: UNITED KINGDOM , 51 years of age, Patient experienced the following unwanted or unexpected effects: air embolism, blood pressure decreased, cardiac disorder, end-tidal co2 decreased, extrasystoles, heart rate decreased, medical device complication, oxygen saturation decreased, procedural complication. During the same period patient was treated with PRESSURE REGULATOR DEVICE (2 Bars Of Pressure) (View Pressure Regulator Device Review and Pressure Regulator Device Label ).

6548973-5 | Air Embolism, Aspiration, End-tidal Co2 Decreased, Extrasystoles, Heart Rate Decreased, Oxygen Saturation Decreased, Procedural Complication
on Dec 30, 2009 Male patient from UNITED KINGDOM , 51 years of age, was diagnosed with haemostasis and was treated with Evicel (View Usage). Patient had the following side effects: air embolism, aspiration, end-tidal co2 decreased, extrasystoles, heart rate decreased, oxygen saturation decreased, procedural complication. Evicel dosage: . During the same period patient was treated with PRESSURE REGULATOR DEVICE (View Pressure Regulator Device Review and Pressure Regulator Device Label ).

6530086-X | Mycobacterium Chelonei Infection, Wound Infection
on Nov 22, 2009 Female patient from UNITED STATES , 56 years of age, weighting 225.0 lb, was diagnosed with abdominal hernia repair and was treated with Evicel (View Usage). After Evicel was administered, patient had the following side effects: mycobacterium chelonei infection, wound infection. Evicel dosage: .

6463126-7 | Off Label Use, Wound Dehiscence
Patient was taking Evicel (View Usage). Patient experienced the following unwanted or unexpected effects: off label use, wound dehiscence on Oct 26, 2009 from UNITED STATES Additional patient health information: Male patient , 49 years of age, was diagnosed with haemostasis, pterygium operation, wound closure and. Evicel dosage: 1 Ml, Once, Topical.

6463125-5 | Off Label Use, Wound Dehiscence
Adverse event was reported on Oct 26, 2009 by a Male patient taking Evicel (View Usage) (Dosage: 1 Ml, Once, Topical) was diagnosed with haemostasis, pterygium operation, wound closure and. Location: UNITED STATES , 66 years of age, Patient had the following side effects: off label use, wound dehiscence.

6463112-7 | Mycobacterium Chelonei Infection, Wound Infection
on Oct 20, 2009 Female patient from UNITED STATES , 56 years of age, weighting 225.0 lb, was diagnosed with abdominal hernia repair, small intestinal resection and was treated with Evicel (View Usage). After Evicel was administered, patient had the following side effects: mycobacterium chelonei infection, wound infection. Evicel dosage: .

6460791-5 | Off Label Use, Wound Dehiscence
on Oct 26, 2009 Male patient from UNITED STATES , 65 years of age, was diagnosed with haemostasis, pterygium operation, wound closure and was treated with Evicel (View Usage). Patient experienced the following unwanted or unexpected effects: off label use, wound dehiscence. Evicel dosage: 1 Ml, Once, Topical.

6460789-7 | Off Label Use, Wound Dehiscence
Patient was taking Evicel (View Usage). Patient had the following side effects: off label use, wound dehiscence on Oct 26, 2009 from UNITED STATES Additional patient health information: Female patient , 66 years of age, was diagnosed with haemostasis, pterygium operation, wound closure and. Evicel dosage: 1 Ml, Once, Topical.

6440924-7 | Mycobacterium Chelonei Infection, Off Label Use, Wound Infection
Adverse event was reported on Nov 13, 2009 by a Female patient taking Evicel (View Usage) (Dosage: ??) was diagnosed with abdominal hernia repair and. Location: UNITED STATES , 56 years of age, weighting 225.0 lb, After Evicel was administered, patient had the following side effects: mycobacterium chelonei infection, off label use, wound infection.

6268014-7 | Cellulitis, Disease Recurrence, Lipoma, Soft Tissue Inflammation
on Jun 28, 2009 Female patient from UNITED STATES , 53 years of age, weighting 137.0 lb, was treated with Evicel (View Usage). Patient experienced the following unwanted or unexpected effects: cellulitis (What is cellulitis?), disease recurrence, lipoma, soft tissue inflammation. Evicel dosage: .

6262861-3 | Excessive Granulation Tissue, Fat Necrosis, Haemorrhage, Post Procedural Complication, Soft Tissue Inflammation
on Jun 16, 2009 Female patient from UNITED STATES , 53 years of age, weighting 137.0 lb, was treated with Evicel (View Usage). Patient had the following side effects: excessive granulation tissue, fat necrosis, haemorrhage, post procedural complication, soft tissue inflammation. Evicel dosage: .

6184060-6 | Air Embolism, Cardiac Arrest, Haemodynamic Instability
Patient was taking Evicel (View Usage). After Evicel was administered, patient had the following side effects: air embolism, cardiac arrest (What is cardiac arrest?), haemodynamic instability on Oct 02, 2008 from UNITED STATES Additional patient health information: Female patient , 22 years of age, was diagnosed with haemostasis and. Evicel dosage: Once.

6032269-4 | Cardiac Arrest, Haemodynamic Instability
Adverse event was reported on Dec 08, 2008 by a Female patient taking Evicel (View Usage) (Dosage: Once) was diagnosed with haemostasis and. Location: UNITED STATES , 22 years of age, weighting 140.0 lb, Patient experienced the following unwanted or unexpected effects: cardiac arrest (What is cardiac arrest?), haemodynamic instability.

6025875-4 | Air Embolism, Cardiac Arrest, Haemodynamic Instability
on Oct 02, 2008 Female patient from UNITED STATES , 22 years of age, was diagnosed with haemostasis and was treated with Evicel (View Usage). Patient had the following side effects: air embolism, cardiac arrest (What is cardiac arrest?), haemodynamic instability. Evicel dosage: Once.

5624740-1 | Dural Tear, Fluid Retention, Post Procedural Complication, Wound Secretion
on Jan 17, 2008 Male patient from UNITED STATES , 13 years of age, was diagnosed with scoliosis and was treated with Evicel (View Usage). After Evicel was administered, patient had the following side effects: dural tear, fluid retention, post procedural complication, wound secretion. Evicel dosage: . Patient was hospitalized.