BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    50-12242 MINOR VAGINAL PACK

    MDR report key: 413762 · Received August 23, 2002

    Report

    Report Number
    1034876-2002-00005
    Event Type
    Malfunction
    Date Received
    August 23, 2002
    Report Date
    July 22, 2002
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NEEDLE COUNTER HINGES ARE BREAKING AND MAGNETS ARE NOT HOLDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 50-12242 MINOR VAGINAL PACK CONVENIENCE PACK KDD DEROYAL INDUSTRIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening| O