BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISLAND DRESSING, 4" X 4¿ - 16-0044-0

    MDR report key: 23061887 · Received September 16, 2025

    Report

    Report Number
    MW5176093
    Event Type
    Injury
    Date Received
    September 16, 2025
    Date of Event
    August 28, 2025
    Report Date
    September 9, 2025
    Manufacturer
    RITMED / AMD MEDICOM INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT'S WIFE (B)(6) CALLED (B)(6) CUSTOMER SERVICE STATING THE RITMED ISLAND DRESSING RIPS THE PATIENT¿S SKIN AS ITS TOO STICKY. STATED THE MEDICAL ACTION BRAND IS BETTER AND WOULD LIKE THAT OPTION WHEN PLACING ORDERS. 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
    2667959 ISLAND DRESSING, 4" X 4¿ - 16-0044-0 TAPE AND BANDAGE, ADHESIVE KGX RITMED / AMD MEDICOM INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown