BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMD-RITMED 4X4, ISLAND DRESSING

    MDR report key: 21436461 · Received February 21, 2025

    Report

    Report Number
    MW5166692
    Event Type
    Injury
    Date Received
    February 21, 2025
    Date of Event
    January 16, 2025
    Report Date
    February 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) NURSE ((B)(6)) CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT THAT PATIENT (B)(6)) BREAKS OUT WITH RASH WHEN USING ISLAND DRESSING. 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
    408541 AMD-RITMED 4X4, ISLAND DRESSING DRESSING, WOUND, DRUG FRO AMD- RITMED/AMD MEDICOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown