BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4X4, ISLAND DRESSING, STERLINE

    MDR report key: 23920865 · Received December 29, 2025

    Report

    Report Number
    MW5181374
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    December 11, 2025
    Report Date
    December 18, 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 CAREGIVER OF A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED CUSTOMER SERVICE TO REPORT THAT THE PATIENT IS ALLERGIC TO THE 4X4, ISLAND DRESSING, STERILE. SHE DOES NOT NEED ANYTHING REPLACED, SHE JUST WANTED TO MAKE US AWARE. 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
    2272032 4X4, ISLAND DRESSING, STERLINE TAPE AND BANDAGE, ADHESIVE KGX AMD MEDICOM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown