BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MENTOR

    MDR report key: 3030372 · Received March 27, 2013

    Report

    Report Number
    MW5029550
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MENTOR
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD SILICONE BREAST IMPLANTS SLIPPED AND FELL IN THE SHOWER STRIKING THE LEFT BREAST. A SMALL DEHISCENCE OF THE WOUND WAS NOTICED BY THE PT WITH SILICONE LEAKING THROUGH. PT ADMITTED FOR OBSERVATION AND ANTIBIOTICS. IMPLANT WAS REMOVED (B)(6) 2013 AND SURGEON REQUESTS THAT IT BE SENT BACK TO THE MANUFACTURER FOR QUALITY TESTING. PERMISSION FROM PT OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125302 MENTOR GEL ROUND SMOOTH SILICONE BREAST IMPLANT FTR MENTOR 6609677

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization