BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KLING

    MDR report key: 292053 · Received August 22, 2000

    Report

    Report Number
    MW1019761
    Event Type
    Injury
    Date Received
    August 22, 2000
    Date of Event
    June 11, 2000
    Report Date
    August 16, 2000
    Manufacturer
    JOHNSON & JOHNSON MEDICAL INC.
    Product Code
    EFN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING DRESSING CHANGE A BLACK SPOT WAS NOTED ON DRESSING NEAR THE END OF THE ROLL. THE COMPLETE BANDAGE WAS REMOVED IMMEDIATELY. NEW ROLL OF BANDAGE USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KLING FLUFF ROLL BANDAGE EFN JOHNSON & JOHNSON MEDICAL INC. * 200013610304

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention