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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MENTOR SILICONE COHESIVE GEL IMPLANTS

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MENTOR SILICONE COHESIVE GEL IMPLANTS Back to Search Results
Model Number 350-730BC
Event Date 05/01/2007
Event Type  Injury  
Event Description

I had mentor cohesive gel implants placed. The implanting surgeon ran a suture through the implant when placing them, they began leaking soon after placement. Within 3 months, my health took a sharp decline with life threatening arrhythmia issues which required cardiac ablation and meds. Also. I started to have rapidly degenerating joints and have had 5 ortho surgeries including joint replacements. I also developed severe reactions to some foods.

 
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Brand NameSILICONE COHESIVE GEL IMPLANTS
Type of DeviceSILICONE COHESIVE GEL IMPLANTS
Manufacturer (Section D)
MENTOR
MDR Report Key6773145
Report NumberMW5071414
Device Sequence Number1
Product CodeFTR
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 08/05/2017
2 DeviceS WERE Involved in the Event: 1   2  
1 Patient Was Involved in the Event
Date FDA Received08/05/2017
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number350-730BC
Device LOT Number(L) 5710109
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/05/2017 Patient Sequence Number: 1
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