BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIMORA SILICONE FOAM DRESSING WITH BORDER

    MDR report key: 21676353 · Received March 24, 2025

    Report

    Report Number
    3005076849-2025-00002
    Event Type
    Injury
    Date Received
    March 24, 2025
    Date of Event
    February 18, 2025
    Report Date
    March 6, 2025
    Manufacturer
    WINNER MEDICAL CO.,LTD.
    Product Code
    NAD
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    1.1. THE LAYER OF THE SILICONE FOAM DRESSING WHICH CONTACTS WITH THE SKIN DIRECTLY IS THE SILICONE NET CONTACT LAYER. IT PROVIDES GENTLE ADHESION AND SECURE FIXATION, MINIMIZES PAIN AND TRAUMA WITHOUT DAMAGING THE WOUND OR SURROUNDING SKIN WHEN DRESSING CHANGES, AND ENHANCES PATIENT'S COMFORT. WITH LOW ADHESION, THE SILICONE FOAM DRESSING WOULD NOT TEAR THE SKIN UNDER NORMAL CIRCUMSTANCE. 2. DUE TO NOT LOT PROVIDED, WE HAVE CHECKED THE ADHESION OF ALL BATCHES WHICH WITHIN THE VALIDITY PERIOD.IT IS FOUND THAT THE ADHESION OF THE SILICONE FOAM DRESSING IS ALL WITHIN 0.5N/CM, WHICH WHITHIN THE INTERNAL STANDARD REQUIREMENT. 3.THE IFU OF THE PRODUCT HAS ALSO MENTION OF THE INTENDED USE AND CONTRAINDICATIONS DURING THE USE. 4.THE PRINCIPLE OF THE DRESSING IS PROVIDING A MOIST WOUND HEALING ENVIRONMENT TO ACCELERATE THE WOUND HEALING. AND THE PRODUCT IS USED FOR WOUND WITH MEDIUM TO HIGH EXUDATION. FOR THE WOUND OF DRY OR WITH LESS EXUDATION, THE WOUND SHOULD BE VERY FRAGILE AND NOT SUITABLE FOR APPLYING THE DRESSING. THE ADHESION OF THE SILICONE WOULD DECREASE WHILE CONTACT WITH WET WOUND, BUT FOR THE DRY WOUND, IT MIGHT TEAR THE SKIN AND CAUSE THE BLEEDING. THEREFORE, IT IS SUSPECTED THAT THE WOUND OF THE CUSTOMER WAS RELATIVELY DRY AND COULD NOT USE THE SILICONE FOAM DRESSING.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447110 DIMORA SILICONE FOAM DRESSING WITH BORDER DRESSING, WOUND, DRUG NAD WINNER MEDICAL CO.,LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female