MENTOR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-26 for MENTOR * manufactured by Mentor Texas, Inc..

Event Text Entries

[312972] Had cheek implants implanted through the mouth 2 years ago. This whole process was catastrophic. Had to have left one removed due to infection and reinserted 6 mos later. Big mistake. Not only did pt have chronic candidiasis or systemic fungal infection, the devices are faulty. Pt has become so ill from the toxins that the implants are made up of. Pt has chronic fatigue syndrome, joints and bones ache, memory loss, chronic constipation, trouble concentrating and symptoms of ms, lupus and a host of other auto immune diseases. Rptr feels these medical devices are toxic dangerous and aren't fit for any human being. Pt is on the road to disabled and prior to all this pt was extremely healthy and very happy and energetic. Pt also had mentor breast implants which pt had removed because of all the symptoms as described above.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1033862
• MDR Report Key: 562103
• Date Received: 2004-11-26
• Date of Report: 2004-11-26
• Date of Event: 2004-11-26
• Date Added to Maude: 2004-12-30
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: MENTOR
• Generic Name: MALAR IMPLANTS
• Product Code: LZK
• Date Received: 2004-11-26
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 551818
• Manufacturer: MENTOR TEXAS, INC.
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: MENTOR
• Generic Name: BREAST IMPLANTS
• Product Code: FWM
• Date Received: 2004-11-26
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 2
• Device Event Key: 551822
• Manufacturer: MENTOR TEXAS, INC.
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit	2004-11-26