BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISLAND DRESSING, 4" X 4¿

    MDR report key: 23222367 · Received October 6, 2025

    Report

    Report Number
    MW5176941
    Event Type
    Injury
    Date Received
    October 6, 2025
    Date of Event
    September 17, 2025
    Report Date
    September 30, 2025
    Manufacturer
    AMD-RITMED, INC./ AMD MEDICOM INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT BLOOD BLISTERS UNDER ISLAND DRESSING ADHESIVE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2477980 ISLAND DRESSING, 4" X 4¿ TAPE AND BANDAGE, ADHESIVE KGX AMD-RITMED, INC./ AMD MEDICOM INC. A50044 15132

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown