MAUDE Adverse Event Report: MENTOR SILICONE COHESIVE GEL IMPLANTS

Lot Number	(R) 5635876
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Arrhythmia (1721); Complaint, Ill-Defined (2331); Joint Disorder (2373); Reaction (2414)
Date of Event	05/01/2007
Type of Reportable Event	Serious Injury
Event or Problem 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.

• Brand Name: SILICONE COHESIVE GEL IMPLANTS
• Common Device Name: SILICONE COHESIVE GEL IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 6773145
• Report Number: MW5071414
• Device Sequence Number: 9481046
• Product Code: FTR
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 08/05/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Device Lot Number: (R) 5635876
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Disability
• Patient Age: 56 YR
• Patient Weight: 64