BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4X4, ISLAND DRESSING, STERILE 50/BX

    MDR report key: 25015282 · Received April 27, 2026

    Report

    Report Number
    MW5187345
    Event Type
    Injury
    Date Received
    April 27, 2026
    Report Date
    April 22, 2026
    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 ISLAND DRESSING IRRITATES HIS SKIN. THERE WAS PATIENT INVOLVEMENT, AND ADVERSE EVENT WAS REPORTED. 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
    1055109 4X4, ISLAND DRESSING, STERILE 50/BX TAPE AND BANDAGE, ADHESIVE KGX AMD MEDICOM INC 16-0044-0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown