MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number	350-1680
Medical Device Problem Codes	Material Rupture (1546); Defective Component (2292); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Pain (1994); Swollen Lymph Nodes (2093); Fungal Infection (2419); No Code Available (3191)
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.Manufacturer's ref.No: (b)(4).
Event or Problem 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. .

• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• MDR Report Key: 6643555
• Report Number: 1645337-2017-00038
• Device Sequence Number: 1322965
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2017

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: 350-1680
• Device Lot Number: UNKNOWN
• Other Device ID Number: 350-1680
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2017
• Initial Report FDA Received Date: 06/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1