BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMD RITMED INC DRESSING (TRANSPARENT / ISLAND) - ISLAND DRESSING

    MDR report key: 22370339 · Received June 30, 2025

    Report

    Report Number
    MW5172137
    Event Type
    Injury
    Date Received
    June 30, 2025
    Date of Event
    June 6, 2025
    Report Date
    June 26, 2025
    Manufacturer
    AMD- RITMED/AMD MEDICOM, INC.
    Product Code
    FRO
    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 REPORT AN ISLAND DRESSING. THE PATIENT ADVISED THAT THE ISLAND DRESSING GAVE HER A RASH WHILE USING AND NOTICED ABOUT THREE WEEKS AGO. THE REGISTERED NURSE ADVISED PATIENT TO STOP USING ISLAND DRESSING AND USE A STERILE GAUZE. 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
    1313365 AMD RITMED INC DRESSING (TRANSPARENT / ISLAND) - ISLAND DRESSING DRESSING, WOUND, DRUG FRO AMD- RITMED/AMD MEDICOM, INC. A50044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown