BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMD-RITMED 4X4, ISLAND DRESSING

    MDR report key: 21643684 · Received March 19, 2025

    Report

    Report Number
    MW5167810
    Event Type
    Injury
    Date Received
    March 19, 2025
    Date of Event
    February 25, 2025
    Report Date
    March 14, 2025
    Manufacturer
    AMD- RITMED/AMD MEDICOM, INC.
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT THE TAPE FROM THE ISLAND DRESSING IRRITATES HER SKIN WHEN SHE USES IT. 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
    336856 AMD-RITMED 4X4, ISLAND DRESSING DRESSING, WOUND, DRUG FRO AMD- RITMED/AMD MEDICOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown