BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4X4, ISLAND DRESSING, STERILE 50/BX A50044

    MDR report key: 23932910 · Received December 30, 2025

    Report

    Report Number
    MW5181524
    Event Type
    Injury
    Date Received
    December 30, 2025
    Report Date
    December 22, 2025
    Manufacturer
    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 (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THAT THE ISLAND DRESSINGS CAUSED HER TO BREAK OUT, BECOME SEVERELY ITCHY, AND SHE ENDED UP GETTING DERMATITIS. NO RGA OR REKEY ORDER NEEDED AS THE PATIENT DOES NOT USE THE PRODUCT, AND HER ACCOUNT HAS BEEN PUT ON HOLD, PER HER PD NURSE (B)(6). THE PATIENT CALLED IN WANTING TO PLACE AN ORDER FOR ANCILLARIES. 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
    2708223 4X4, ISLAND DRESSING, STERILE 50/BX A50044 TAPE AND BANDAGE, ADHESIVE KGX AMD MEDICOM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown