MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SILTEX ROUND MODERATE PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	3542620
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Autoimmune Reaction (1733)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient of unknown age who underwent breast augmentation with a (left) 175cc mentor siltex round moderate profile and a (right) 175cc mentor smooth round moderate profile saline breast prostheses, suffered right breast implant deflation was diagnosed with monoclonal gammapathy and an autoimmune disease, post-operatively.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This medwatch form is for the left breast prosthesis.
Additional Manufacturer Narrative
A manufacturing record evaluation (mre) was performed for the complaint device.As a result, the manufacturing date and expiration date fields have been updated.The manufacturing record evaluation (mre) was reviewed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX ROUND MODERATE PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9413902
• Report Number: 1645337-2019-25103
• Device Sequence Number: 1834652
• Product Code: FWM
• UDI-Device Identifier: 00081317001737
• UDI-Public: 00081317001737
• Combination Product (Y/N): N
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2019

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 Expiration Date: 07/31/2006
• Device Model Number: 3542620
• Device Catalogue Number: 3542620
• Device Lot Number: 247528
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 02/04/2020
• 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: Other