MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number	UNKNOWN SALINE IMPLANT
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Pain (1994); Thyroid Problems (2102); Weakness (2145); No Code Available (3191)
Date of Event	09/30/2013
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.(b)(4).The device was not returned to mentor.
Event or Problem Description
This is event was reported via # mw5034717.It was reported that a female patient received bilateral augmentation mammoplasty in 1998.The patient reported that in mid 2013 she experienced breast pain in the right breast and skin rash and swelling in her right side.These symptoms have been lasting for 4-5 years.The patient reported easy bruising and body swelling.She was diagnosed as biotoxin illness, silicone sensitivity from the silicon shell of the saline implant, mold coming from the implant.According to her physician fibromyalgia, mastodynia, hashimoto¿s thyroiditis and raynaud¿s disease were false positive and her illness was actually due to the biotoxin disease from the mold.

• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• MDR Report Key: 6734648
• Report Number: 1645337-2017-00045
• Device Sequence Number: 1332003
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Type of Report: Initial
• Report Date (Section B): 07/21/2017

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2017
• Initial Report FDA Received Date: 07/21/2017
• 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