BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JODEE BRA

    MDR report key: 179950 · Received July 30, 1998

    Report

    Report Number
    MW1014272
    Event Type
    Malfunction
    Date Received
    July 30, 1998
    Date of Event
    July 1, 1998
    Report Date
    July 30, 1998
    Manufacturer
    JODEE BRA, INC.
    Product Code
    KCZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR WORE PRODUCT ONCE, "SOMETHING OOZED OUT". RPTR SENT IT BACK TO MFR WHO WOULD NOT EVALUATE THE PRODUCT OR GIVE HER A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JODEE BRA EXTERNAL BREAST PROSTHESIS KCZ JODEE BRA, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR