MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number	UNKNOWN SALINE IMPLANT
Medical Device Problem Codes	Defective Component (2292); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Autoimmune Disorder (1732); No Code Available (3191)
Date of Event	06/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was reported via medwatch form # mdr mw5070517 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.(b)(4).The product is not returned.
Event or Problem Description
It was reported that a female patient was implanted with mentor smooth saline breast implants in 2002.She stated that her immune system was getting worse since implantation as she experienced autoimmune symptoms.She also reports headaches, brain fog, joint pain, body aches, chronic fatigue, dry eyes, weight loss, digestive system issues, sore feet, and increased recovery period from any surgery.She claimed that the implants were removed in 2016.The implants were found with faulty valves and mold.She also claimed that the implants caused harm to her children during pregnancy and breastfeeding as her children's immune system were over-reactive to everything.

• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• MDR Report Key: 6786582
• Report Number: 1645337-2017-00050
• Device Sequence Number: 1672103
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Type of Report: Initial
• Report Date (Section B): 07/11/2017

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: UNKNOWN SALINE IMPLANT
• Other Device ID Number: UNKNOWN SALINE IMPLANT
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 08/10/2017
• 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