BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISLAND DRESSING

    MDR report key: 23358690 · Received October 22, 2025

    Report

    Report Number
    MW5177813
    Event Type
    Injury
    Date Received
    October 22, 2025
    Date of Event
    September 19, 2025
    Report Date
    October 15, 2025
    Manufacturer
    AMD RITMED/ AMD MEDICOM INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THAT THE ISLAND DRESSINGS ADVISED THAT THE ISLAND DRESSING PULLS SKIN OFF AND MAKES HER BLEED WHEN REMOVED. 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
    231668 ISLAND DRESSING TAPE AND BANDAGE, ADHESIVEDRESSING KGX AMD RITMED/ AMD MEDICOM INC. 13948

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown