BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4X4, ISLAND DRESSING, STERILE 50/BX A50044

    MDR report key: 25085357 · Received May 4, 2026

    Report

    Report Number
    MW5187657
    Event Type
    Injury
    Date Received
    May 4, 2026
    Date of Event
    April 3, 2026
    Report Date
    April 23, 2026
    Manufacturer
    AMD MEDICOM INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT AN ISSUE AGAINST THE ISLAND DRESSING 50/BOX. IT WAS REPORTED BY THE PATIENT THAT THIS PRODUCT GETS HIM ITCHY WHEN USING IT. THE PATIENT INVOLVEMENT WAS UNKNOWN, HOWEVER THERE WAS A HARM OR ADVERSE EVENT 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
    99192 4X4, ISLAND DRESSING, STERILE 50/BX A50044 TAPE AND BANDAGE, ADHESIVE KGX AMD MEDICOM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown