BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR SILTEX CONTOUR PROFILE HIGH

    MDR report key: 10045100 · Received May 11, 2020

    Report

    Report Number
    1645337-2020-06177
    Event Type
    Injury
    Date Received
    May 11, 2020
    Date of Event
    November 26, 2019
    Manufacturer
    MENTOR TEXAS
    Product Code
    FWM
    UDI-DI
    00081317001904
    PMA / PMN Number
    P990075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION WAS UPDATED ON (B)(6) 2020 TO ADD THE FOLLOWING: MICROSCOPIC EXAMINATION IN THE EDGES OF THE FIVE TEARS REVEALED PARALLEL STRIATIONS THAT ARE CONSISTENT WITH MARKINGS MADE BY A SHARP INSTRUMENT PERFORATING SILICONE MATERIAL. MENTOR CONCLUDED THAT THE CAPSULAR CONTRACTURE IN THE PATIENT´S BREAST WAS THE RESULT OF THE BODY´S INDIVIDUAL PHYSIOLOGICAL RESPONSE TO THE IMPLANTATION OF A FOREIGN OBJECT IN SOFT TISSUE. CAPSULAR CONTRACTURE IS A KNOWN COMPLICATION ASSOCIATED WITH THESE DEVICES AND IS REFERENCED IN OUR CURRENT PRODUCT INSERT DATA SHEET. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: A MANUFACTURING RECORD EVALUATION (MRE) WAS PERFORMED FOR THE FINISHED DEVICE NUMBER 213334, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT WERE IDENTIFIED. DURING VISUAL EVALUATION OF THE DEVICE, FOUR TEARS WERE OBSERVED. TEAR A MEASURES 4.2 CM, TEAR B MEASURES 2.6 CM, TEAR C MEASURES 0.5 CM AND TEAR D MEASURES 1.2 CM. TEAR A WAS OBSERVED ON THE POSTERIOR VIEW AND TEARS B, C AND D WERE FOUND ON THE ANTERIOR VIEW. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF LOT 213334 WERE REVIEWED AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS LOT. EACH DEVICE IS VISUALLY INSPECTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. REASON FOR DEVICE EXPLANT AND/OR REOPERATION: CAPSULAR CONTRACTURE/POSSIBLE DEFLATION. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) YEAR OLD FEMALE WHO UNDERWENT BREAST RECONSTRUCTION REVISION WITH MENTOR SILTEX CONTOUR PROFILE HIGH 275CC SALINE PROSTHESES EXPERIENCED POSSIBLE LEFT SIDED DEFLATION AND BILATERAL CAPSULAR CONTRACTURE (BAKER GRADE UNKNOWN) POST PROCEDURE. IT WAS ALSO INDICATED THAT REPLACEMENT WAS DESIRED DUE TO THE AGE OF THE IMPLANTS. AS A RESULT, BILATERAL REPLACEMENT WITH ALLERGAN PROSTHESES WAS PERFORMED ON (B)(6) 2020. SEE 1645337-2020-06176 FOR CONTRALATERAL PROSTHESIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508400 MENTOR SILTEX CONTOUR PROFILE HIGH PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE FWM MENTOR TEXAS 3542711 213334 00081317001904

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention