BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 520326 · Received March 22, 2004

    Report

    Report Number
    MW1031616
    Event Type
    Malfunction
    Date Received
    March 22, 2004
    Date of Event
    May 1, 2002
    Report Date
    March 22, 2004
    Manufacturer
    CAMP INT., INC.
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAD A SILICONE BREAST PROSTHESIS IN 1999. THE LEFT SIDE PROSTHESIS WAS DEFECTIVE AND BROKE DOWN. IT WAS REPLACED IN 2001. AT THIS TIME THE REPLACEMENT WAS FOLDED AND BROKE DOWN IN LESS THAN A YEAR. A TWO YEAR WARRANTY WAS GIVEN BY THE COMPANY BUT THEY NEVER KEPT THEIR SIDE OF THE AGREEMENT. THE SILICONE PROSTHESIS BREAKS DOWN ACCORDING TO THE PT BECAUSE THEY DID NOT HOLD THEIR SHAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * BREAST PROSTHESIS FTR CAMP INT., INC. 50SL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR