BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURAD

    MDR report key: 246201 · Received October 26, 1999

    Report

    Report Number
    MW1017405
    Event Type
    Malfunction
    Date Received
    October 26, 1999
    Date of Event
    October 25, 1999
    Report Date
    October 26, 1999
    Manufacturer
    BEIERSDORF, INC.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    AFTER USING 8 BANDAGES FROM THE BOX FOR A SMALL FINGER LACERATION, THE CHILD DISCOVERED TWO BANDAGES IN THE BOX THAT HAD BEEN SEALED WITH SCOTCH TAPE AS OPPOSED TO THE NORMAL SEALED, STERILE PACKAGING. IT IS ALSO NOTED THAT THE OUTER BOX DOESN'T HAVE ANY SORT OF TAMPER-PROOF SEAL. FAMILY CONSULTED PEDIATRICIAN. NO TREATMENT REQUIRED. MFR AND DISTRIBUTOR WERE INFORMED AND PACKAGE WAS RETURNED TO MFR FOR TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURAD SCOOBY DOO BANDAGE KGX BEIERSDORF, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR