MAUDE Adverse Event Report: MENTOR MENTOR IMPLANTS

Device Problem Defective Component (2292)

Patient Problems Rheumatoid Arthritis (1724); Fungus (1872); Lupus (1956); Sjogren's Syndrome (2073); Disability (2371)

Event Date 07/13/2015

Event Type  Injury  

Event Description

I had implants put in 10 years ago.I immediately became ill with migraines, rheumatoid arthritis, pots, sjogrens, lupus and celiac disease.I was disabled for many years.I explanted on (b)(6) 2015 and found the valves to my mentor implants were faulty and created a situation where mold was present.I am doing 95% better and don't have any signs of 4 out of 5 autoimmune issues.They ruined 10 years of my life and because of my age, i missed having children because i was so sick.

• Brand Name: MENTOR IMPLANTS
• Type of Device: MENTOR IMPLANTS
• Manufacturer (Section D): MENTOR
• MDR Report Key: 5332814
• MDR Text Key: 34678959
• Report Number: MW5058779
• Device Sequence Number: 1
• Product Code: FTR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Disability
• Patient Age: 32 YR
• Patient Weight: 62