BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISLAND DRESSING, STERILE 50/BX

    MDR report key: 23862749 · Received December 22, 2025

    Report

    Report Number
    MW5180860
    Event Type
    Injury
    Date Received
    December 22, 2025
    Date of Event
    July 17, 2025
    Report Date
    December 12, 2025
    Manufacturer
    AMD-RITMED INC. / 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

    COMPLAINT INVOLVES A DEVICE ASSOCIATED WITH AN ADVERSE EVENT THAT IS NOT MANUFACTURED BY (B)(6) MEDICAL CARE NORTH AMERICA. A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED TO CUSTOMER SERVICE TO REPORT THE SILK TAPE MAKES HER BREAKOUT WITH RASHES AND SHE DOES NOT NEED ANYTHING REPLACED, THE PATIENT INVOLVEMENT WAS 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
    1661717 ISLAND DRESSING, STERILE 50/BX TAPE AND BANDAGE, ADHESIVE KGX AMD-RITMED INC. / AMD MEDICOM INC. A50044 14720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown