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Infuse FDA adverse reports: 2. View All Infuse FDA Adverse Reports

Infuse FDA safety alerts: 2009

Reported hospitalizations: 1

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Infuse Adverse Effect Reports (FDA)
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Infuse Side Effects Report: 6083113-0,Impaired Work Ability, Procedural Pain, Product Quality Issue
on Feb 17, 2009 Female patient from UNITED STATES, , weighting 159.0 lb, was diagnosed with intervertebral disc protrusion and was treated with Infuse. After Infuse was administered, patient had the following side effects: Infuse and impaired work ability, Infuse and procedural pain, Infuse and product quality issue. Infuse dosage: .

Infuse Side Effects Report: 5671850-9,Back Pain, Confusional State, Gout, Mental Status Changes, Pericardial Effusion, Post Procedural Infection, Pulmonary Embolism, Renal Failure Acute, Sepsis
on Mar 18, 2008 Male patient from UNITED STATES, , weighting 224.9 lb, was diagnosed with spinal fusion surgery, surgical failure and was treated with Infuse. After Infuse was administered, patient had the following side effects: Infuse and back pain (What is back pain?), Infuse and confusional state, Infuse and gout (What is gout?), Infuse and mental status changes, Infuse and pericardial effusion, Infuse and post procedural infection, Infuse and pulmonary embolism (What is pulmonary embolism?), Infuse and renal failure acute, Infuse and sepsis (What is sepsis?). Infuse dosage: 8 Cc Once Intradiscal. During the same period patient was treated with INFUSE BONE GRAFT MEDTRONIC. Patient was hospitalized.


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Brand Name:INFUSE - BONE GRAFT Generic Name:BONE GRAFT SUBSTITUTE Manufacturer Name:MEDTRONIC SOFAMOR DANEK USA, INC. Manufacturer Address: 4340 SWINNEA RD.

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Infuse Side Effects
Infuse and Back painWhat is Back pain?
Infuse and Confusional state
Infuse and GoutWhat is Gout?
Infuse and Impaired work ability
Infuse and Mental status changes
Infuse and Pericardial effusion
Infuse and Post procedural infection
Infuse and Procedural pain
Infuse and Product quality issue
Infuse and Pulmonary embolismWhat is Pulmonary embolism?
Infuse and Renal failure acute
Infuse and SepsisWhat is Sepsis?

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