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

Model Number	3542712
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	02/15/2020
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: material rupture, capsular contracture manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old white hispanic female patient, who's undergone breast augmentation with two 350cc mentor siltex contour profile high saline breast prostheses, suffered spontaneous right breast implant deflation and bilateral breast capsular contractures (baker grade unknown), post-procedure.The right breast deflation was initially self-diagnosed by the patient and was also diagnosed with left breast capsular contracture during an in-office visit.The right capsular contracture was diagnosed during the revision surgery on (b)(6) 2021.The patient subsequently underwent bilateral complete capsulectomies and bilateral removal and replacement of the implants.The replacement devices were the following: (right) 225cc mentor smooth round moderate profile saline catalog: 3501630 lot: 9556176 sn: (b)(4) and (left) 225cc mentor smooth round moderate profile saline catalog: 3501630 lot: 9534032 sn: (b)(4).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 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: 12155903
• Report Number: 1645337-2021-07832
• Device Sequence Number: 3965787
• Product Code: FWM
• UDI-Device Identifier: 00081317001911
• UDI-Public: 00081317001911
• 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: 1996
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 04/30/2004
• Device Model Number: 3542712
• Device Catalogue Number: 3542712
• Device Lot Number: 145275
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 07/12/2021
• Supplement Report FDA Received Date: 07/26/2021
• 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