BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4X4,ISLAND DRESSING,STERILE 50/BX A50044

    MDR report key: 24052145 · Received January 12, 2026

    Report

    Report Number
    MW5182063
    Event Type
    Injury
    Date Received
    January 12, 2026
    Date of Event
    December 18, 2025
    Report Date
    December 31, 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 AND MENTIONED HAVING A REACTION TO THE ISLAND DRESSING 16-0044-0. PATIENT STATES THE ADHESIVE CAUSES HIM TO BREAK OUT IN RASH. 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
    111460 4X4,ISLAND DRESSING,STERILE 50/BX A50044 TAPE AND BANDAGE, ADHESIVE KGX AMD MEDICOM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown