BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4X4, ISLAND DRESSING, STERILE 50/BX A50044/16-00440

    MDR report key: 24052001 · Received January 12, 2026

    Report

    Report Number
    MW5182045
    Event Type
    Injury
    Date Received
    January 12, 2026
    Report Date
    December 30, 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

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT THAT THE 16-0044-0, 4X4, ISLAND DRESSING IRRITATES HER SKIN. "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
    108288 4X4, ISLAND DRESSING, STERILE 50/BX A50044/16-00440 TAPE AND BANDAGE, ADHESIVE KGX AMD MEDICOM INC. 14720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown