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

Catalog Number	3542913
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Wrinkling (2613); No Code Available (3191)
Date of Event	10/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: upon receipt by mentor, the device contained fluid with black appearance.Black material was observed within the device.White, red, and yellow material were observed on the shell surface.During visual examination of the device, mentor product analysis lab observed a rent on the posterior view measuring approximately 0.9 cm.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, mentor product analysis lab was precluded from further evaluating the device.No other anomalies were found.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.Mentor product analysis lab concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.The complaint of deflation was confirmed since a rent was found on the device.However, at this point it is not possible to determine the root cause of such damage or the origin of the black, white, red, and yellow material observed.A manufacturing record evaluation (mre) was performed, 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.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.Mentor product analysis lab concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.Based with the information reported and/or the product investigation, there is no evidence that the issue is related with manufacturing.Breast implants are not considered lifetime devices and deflation is a known complication associated with these devices and is referenced in our product insert data sheet.Reason for device explant and/or reoperation: rupture.Manufacturer¿s reference number: pc-000286413 this report contains supplemental information for mentor asr reference number 1-z286rb.This device report is being submitted late as a result of the exemption transition period following the revocation of mentor¿s asr exemption #e1999017.
Event or Problem Description
It was reported that a (b)(6) female patient underwent an unknown procedure with mentor siltex contour profile moderate 350cc saline breast prostheses when the right breast prostheses deflated after implantation.In addition, the patient developed rippling in both breasts.As a result, the patient underwent bilateral explantation on (b)(6) 2018.This medwatch report is for the right breast prosthesis.This report contains supplemental information for mentor asr reference number 1-z286rb.

• Brand Name: MENTOR SILTEX CONTOUR PROFILE MODERATE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8936001
• Report Number: 1645337-2019-17920
• Device Sequence Number: 10891009
• Product Code: FWM
• UDI-Device Identifier: 00081317001874
• UDI-Public: 00081317001874
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/25/2014
• Device Catalogue Number: 3542913
• Device Lot Number: 5976540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 08/27/2019
• 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: 49 YR