BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVERLET BANDAGE

    MDR report key: 20765 · Received March 27, 1995

    Report

    Report Number
    MW1005581
    Event Type
    Malfunction
    Date Received
    March 27, 1995
    Date of Event
    March 13, 1995
    Report Date
    March 21, 1995
    Manufacturer
    BEIERSDORF, INC.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THREE REPORTED CASES OF (APPARENT) CELLULITIS/DERMATITIS AFTER REMOVAL OF BANDAGE. APPEARS TO BE A CLUSTER EVENT, WITH NO COMMON DENOMINATOR OTHER THAN BANGAGE. ADD'L EVENT DATES: 3/15/95, 3/17/95.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVERLET BANDAGE KGX BEIERSDORF, INC. 0230 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 *