BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR STYLE 1600 SALINE FILLED BREAST IMPLANT

    MDR report key: 1931322 · Received December 14, 2010

    Report

    Report Number
    MW5018588
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    July 14, 2010
    Report Date
    December 7, 2010
    Manufacturer
    MENTOR CORPORATION
    Product Code
    FWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    RETURN OF DEFLATED SALINE BREAST IMPLANTS GENERATES AN EXAMINATION OF THE DEVICE BY THE MENTOR COMPANY THAT VERY COMMONLY DESCRIBES "PARALLEL STRIATIONS WHICH ARE SIMILAR TO MARKINGS MADE BY A SHARP INSTRUMENT PERFORATING THE SILICONE MATERIAL." SINCE SURGICAL AND POST-SURGICAL PROTOCOLS METICULOUSLY AVOID ANY SHARP INSTRUMENT EXPOSURE OR CONTACT, IT SUGGESTS THAT THESE IMPLANTS ARE BEING DAMAGED BY HANDLING IN THE FACTORY. DIAGNOSIS OR REASON FOR USE: BREAST AUGMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR STYLE 1600 SALINE FILLED BREAST IMPLANT SALINE BREAST IMPLANT FWM MENTOR CORPORATION 1600 5688526

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention