BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TAPE AND BANDAGE, ADHESIVE

    MDR report key: 23061865 · Received September 16, 2025

    Report

    Report Number
    MW5176091
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    September 2, 2025
    Report Date
    September 8, 2025
    Manufacturer
    AMD-RITMED/AMD MEDICOM
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED (B)(6) CUSTOMER SERVICE TO ADVISE THE ISLAND DRESSING IRRITATES HER SKIN, THE PATIENT INVOLVEMENT IS UNKNOWN HOWEVER THERE WAS NO 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
    2640332 TAPE AND BANDAGE, ADHESIVE TAPE AND BANDAGE, ADHESIVE KGX AMD-RITMED/AMD MEDICOM A50044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown