BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4" X 4 50/BX

    MDR report key: 23479433 · Received November 5, 2025

    Report

    Report Number
    MW5178559
    Event Type
    Injury
    Date Received
    November 5, 2025
    Date of Event
    October 8, 2025
    Report Date
    November 4, 2025
    Manufacturer
    AMD-RITMED / AMD MEDICOM
    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 FRESENIUS CUSTOMER SERVICE TO REPORT THAT THE ISLAND DRESSING TAPE IRRITATES HIS SKIN. NO NEW ORDER IS NEEDED AS PATIENT STATED HE WILL NOT CONTINUE TO USE THE ISLAND DRESSING TAPE. THERE WAS PATIENT INVOLVEMENT, AND ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2280903 4" X 4 50/BX TAPE AND BANDAGE, ADHESIVE KGX AMD-RITMED / AMD MEDICOM 16-0044-0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown