BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4X4,ISLAND DRESSING,STERILE 50/BX A50044

    MDR report key: 23468066 · Received November 4, 2025

    Report

    Report Number
    MW5178511
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    October 21, 2025
    Report Date
    October 29, 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 (B)(6) CUSTOMER SERVICE TO REPORT THE ISLAND DRESSING STERILE. PATIENT STATED THAT THE ISLAND DRESSING CAUSES IRRITATION AND MAKES PATIENT ITCH. ADHESIVE CAUSE IRRITATION WHEN SKIN COMES OFF. "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
    2678499 4X4,ISLAND DRESSING,STERILE 50/BX A50044 TAPE AND BANDAGE, ADHESIVE KGX AMD MEDICOM INC. A50044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown