BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMD RITMED INC ISLAND DRESSING, 4" X 4

    MDR report key: 22590121 · Received July 24, 2025

    Report

    Report Number
    MW5173249
    Event Type
    Injury
    Date Received
    July 24, 2025
    Report Date
    July 22, 2025
    Manufacturer
    AMD MEDICOM INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PLEASE NOTE THE ATTACHED COMPLAINT INVOLVES A DEVICE ASSOCIATED WITH AN ADVERSE EVENT THAT IS NOT MANUFACTURED BY (B)(6). A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT THE 4X4 ISLAND DRESSINGS WERE TEARING OFF SKIN WHEN REMOVING DRESSING. HAD TO WAIT TO SCAB OVER TO USE OTHER PRODUCTS. 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
    988688 AMD RITMED INC ISLAND DRESSING, 4" X 4 TAPE AND BANDAGE, ADHESIVE KGX AMD MEDICOM INC. A50044 FD2407A01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown