MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number	UNKNOWN GEL IMPLANT
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Autoimmune Disorder (1732); Breast Mass (2439); No Code Available (3191)
Date of Event	01/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.Manufacturer's ref.No: (b)(4).The product is not returned.
Event or Problem Description
It was reported that a patient alleged autoimmune-like symptoms after using mentor memory gel implants.Her symptoms included rashes, random acne, blackouts to the point the patient stopped driving for safety reasons, severe memory related decline, muscle soreness, extreme fatigue, abnormal thyroid levels, drowsiness, anxiety, and depression.The patient also reported breast pain which appeared in 2016 along with lump in her breast.Mri confirmed that the breast implant had ruptured.In (b)(6) 2016, the patient underwent surgery and the mentor memory gel implants were removed.

• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• MDR Report Key: 6754036
• Report Number: 1645337-2017-00048
• Device Sequence Number: 363182
• Product Code: FTR
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Type of Report: Initial
• Report Date (Section B): 07/28/2017

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: UNKNOWN GEL IMPLANT
• Device Lot Number: UNKNOWN
• Other Device ID Number: UNKNOWN GEL IMPLANT
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2017
• Initial Report FDA Received Date: 07/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability