MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC BREAST IMPLANT

Catalog Number 350-1680

Device Problems Material Rupture (1546); Defective Component (2292); Device Contamination with Chemical or Other Material (2944)

Patient Problems Pain (1994); Swollen Lymph Nodes (2093); Fungal Infection (2419); No Code Available (3191)

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. Manufacturer's ref. No: (b)(4).

Event Description

It was reported that a female patient underwent a breast augmentation surgery using mentor saline smooth round moderate profile implants on (b)(6) 2003. The patient suffered sternal pain, mastodynia and mold infection manifested as enlarged lymph nodes, and was diagnosed bio-toxin disease in 2015. The implants were removed surgically on (b)(6) 2015 and found to have defective valves, internal debris and determined to have been leaking.  .

• 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: 6643555
• Report Number: 1645337-2017-00038
• Device Sequence Number: 1
• Product Code: FWM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 350-1680
• Device Lot Number: UNKNOWN
• Other Device ID Number: 350-1680
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/18/2017
• 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