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

Catalog Number	3542914
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Wrinkling (2613)
Date of Event	10/11/2017
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.The device history record (dhr) was reviewed on 6/14/2018, 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.Concomitant products: right mentor siltex contour profile moderate 425cc saline prosthesis, catalog: 3542914, serial number: (b)(4), lot: 6915639.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old hispanic female patient underwent primary breast augmentation with mentor siltex contour profile moderate 425cc saline prostheses.Bilateral skin rippling and deflation of the breast prostheses were diagnosed post procedure through a physical examination.At the time of this report, mentor has received no information regarding explant date.This report is for the left breast prosthesis.

• 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: 7620994
• Report Number: 1645337-2018-03788
• Device Sequence Number: 1422185
• Product Code: FWM
• UDI-Device Identifier: 00081317001881
• UDI-Public: 00081317001881
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2018

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: 11/18/2019
• Device Catalogue Number: 3542914
• Device Lot Number: 7000878
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2018
• Initial Report FDA Received Date: 06/20/2018
• 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
• Patient Age: 20 YR