BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MENTOR MEMORYGEL BREAST IMPLANT

    MDR report key: 6371540 · Received March 2, 2017

    Report

    Report Number
    6371540
    Event Type
    Malfunction
    Date Received
    March 2, 2017
    Date of Event
    February 24, 2017
    Report Date
    February 28, 2017
    Manufacturer
    MENTOR TEXAS LP
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ABOUT 12 YEARS AGO, PATIENT HAD GEL MAMMARY IMPLANTS PUT IN EACH BREAST. UNKNOWN WHY THEY STARTED LEAKING. FIVE YEARS AGO, PATIENT FOUND TO HAVE A SEROMA IN THE RIGHT BREAST AND THE BREAST HAD A DRAIN PUT IN TO DRAIN IT. THE LEAK WAS DISCOVERED AT THAT TIME BY A MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157534 MENTOR MEMORYGEL BREAST IMPLANT PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED FTR MENTOR TEXAS LP

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other