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

Model Number	3542715
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	08/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.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.Reason for device explant and/or reoperation: capsular contracture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female underwent primary breast augmentation with 650cc saline mentor siltex ontour profile high breast implants and experienced rupture on the left side and capsular contracture on the right side postoperatively.As a result, the patient underwent bilateral device removal on (b)(6) 2020.This report is for the patient's right-sided device.
Additional Manufacturer Narrative
Additional information: on (b)(6) 2020, 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.This report is for the patient's right-sided device.Manufacturer's reference number: (b)(4).

• Brand Name: MENTOR SILTEX CONTOUR PROFILE HIGH
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10497832
• Report Number: 1645337-2020-11091
• Device Sequence Number: 2392228
• Product Code: FWM
• UDI-Device Identifier: 00081317001942
• UDI-Public: 00081317001942
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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: 05/31/2004
• Device Model Number: 3542715
• Device Catalogue Number: 3542715
• Device Lot Number: 211674
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 09/18/2020
• 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: Required Intervention
• Patient Age: 54 YR