MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number	3502350
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	11/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.The device history record (dhr) of lot number 5915659 was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old female patient who underwent breast prostheses implantation in 2009 with mentor saline smooth round moderate plus profile implants 350cc (catalog # 3502350, lot # 5915659) experienced bilateral discomfort and aching.The patient has no history of medical problems.The patient underwent explantation with replacement on (b)(6) 2016 when the surgeon noticed mold in the valve area of both implants :it was described as dark green, brown and black and it was reported that some particles were also in the patient.The surgeon irrigated the cavity and washed it out before inserting new implants.

• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• MDR Report Key: 6810760
• Report Number: 1645337-2017-00059
• Device Sequence Number: 17301874
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2016

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: 3502350
• Device Lot Number: 5915659
• Other Device ID Number: 3502350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2016
• Initial Report FDA Received Date: 08/22/2017
• 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
• Patient Age: 31 YR
• Patient Weight: 66