MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC BREAST IMPLANT

Catalog Number UNKNOWN SALINE IMPLANT

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problems Hypersensitivity/Allergic reaction (1907); Pain (1994); Thyroid Problems (2102); Weakness (2145); No Code Available (3191)

Event Date 09/30/2013

Event Type  Injury  

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 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.

• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• Manufacturer (Section G): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• Manufacturer Contact: carl hansen ; north irving, TX 75038-3540 ; 9497893858
• MDR Report Key: 6734648
• Report Number: 1645337-2017-00045
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKNOWN SALINE IMPLANT
• Other Device ID Number: UNKNOWN SALINE IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

• Patient Outcome(s): Required Intervention; Disability