BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATURAL WEAR BREAST FORMS

    MDR report key: 64587 · Received January 24, 1997

    Report

    Report Number
    MW1010606
    Event Type
    Malfunction
    Date Received
    January 24, 1997
    Date of Event
    December 6, 1996
    Report Date
    January 14, 1997
    Manufacturer
    CAMP INTERNATIONAL INC.
    Product Code
    KCZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER MASTECTOMY DEVICE WAS PRESCRIED BY DR. DEVICE WAS BOUGHT 8/20/94. DEVICE HAS BEEN USED EXACTLY ACCORDING TO CO SPC'S AND AFTER 2YRS, 3 1/2 MONTHS. THE SKIN ON THE INSIDE OF DEVICE SPLIT FROM THE TIGHT SIDE. TO PAST THE NIPPLE. USER FEELS THIS DEVICE SHOULD BE REPLACED BY CO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURAL WEAR BREAST FORMS EXTERNAL BREAST PROSTHESIS KCZ CAMP INTERNATIONAL INC. #509 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other