BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIMORA SILICONE FOAM DRESSING WITH BORDER

    MDR report key: 21413781 · Received February 19, 2025

    Report

    Report Number
    MW5166461
    Event Type
    Injury
    Date Received
    February 19, 2025
    Date of Event
    February 18, 2025
    Report Date
    February 18, 2025
    Manufacturer
    WINNER MEDICAL CO., LTD.
    Product Code
    FRO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    REPORTER CALLED TO SUBMIT HER ADVERSE EVENTS AFTER SHE USED DIMORA SILICONE FOAM DRESSING. SHE SAID SHE APPLIED THE DRESSING ON HER LEFT SHIN LAST NIGHT. WHEN SHE WAS REMOVING IT THIS MORNING, THE BANDAGE OFF, IT TEARS HER SKIN AND ALSO THERE WAS BLEEDING. AFTER SHE CLEANED HER WOUND, SHE APPLIED ANOTHER ONE AND THE SAME THING HAPPENED. SHE SAID WHEN SHE EXAMINES THE TAPE, THE ADHESIVE IS ON THE PAD ITSELF NOT ON THE EDGES TO KEEP THE TAPE ATTACHED TO SKIN. REFERENCE REPORT #MW5166462.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1207903 DIMORA SILICONE FOAM DRESSING WITH BORDER DRESSING, WOUND, DRUG FRO WINNER MEDICAL CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female