BEUDAMED
    FDA Adverse Event Other Summary report: N

    MENTOR

    MDR report key: 75995 · Received January 22, 1997

    Report

    Report Number
    75995
    Event Type
    Other
    Date Received
    January 22, 1997
    Date of Event
    September 19, 1996
    Report Date
    October 7, 1996
    Manufacturer
    MENTOR HS, INC.
    Product Code
    FTR
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NOTED ON MAMMOGRAM RUPTURE TO LEFT BREAST IMPLANT. DURING SURGICAL INTERVENTION IT WAS NOTED THAT LEFT AND RIGHT IMPLANTS WERE RUPTURED. BOTH IMPLANTS WERE REMOVED. IMPLANTS WERE IMPLANTED IN ANOTHER MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MENTOR Implant SILICONE BREAST IMPLANTS FTR MENTOR HS, INC. * L-9644990 R-9514230

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other