MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC; BREAST IMPLANT

Catalog Number	UNKNOWN SALINE IMPLANT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Code Available (3191); Anaplastic Large Cell Lymphoma (3264)
Date of Event	01/13/2017
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.Manufacturer's ref.(b)(4).The device was not returned mentor.
Event or Problem Description
It was reported that a patient (unknown age and gender) with mentor breast prostheses (unknown lot # or catalog #) was diagnosed with alcl (diagnosis date unknown).It was reported by the therapeutic goods association (australian authority) that this includes a confirmed pathology report.No further information is known regarding the patient's medical history, status, hospitalizations, medical or surgical interventions that were performed.Manufacturer site is unknown.Multiple attempts have been made to obtain clarification on patient information as well as catalog, lot number and manufacture site of the devices that were used during this procedure.However, no further information has been made available.Mentor reports this event with an abundance of caution.

• Common Device Name: BREAST IMPLANT
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 3041 skyway circle; north irving TX 75038 3540
• MDR Report Key: 6822978
• Report Number: 1645337-2017-00072
• Device Sequence Number: 1260246
• Product Code: FWM
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Type of Report: Initial
• Report Date (Section B): 01/13/2017

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: Not provided
• Initial Report FDA Received Date: 08/25/2017
• 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: Life Threatening