BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMD-RITMED 4X4, ISLAND DRESSING

    MDR report key: 21721499 · Received March 28, 2025

    Report

    Report Number
    MW5168381
    Event Type
    Injury
    Date Received
    March 28, 2025
    Report Date
    March 26, 2025
    Manufacturer
    AMD-RITMED, INC./ 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 CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THEY HAVE AN ALLERGIC REACTION WITH THE USE OF THE 4X4 ISLAND DRESSING, IT LEAVES BLISTERS AND DISCOLORS HER SKIN. NO FURTHER INFORMATION WAS PROVIDED. "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
    1010454 AMD-RITMED 4X4, ISLAND DRESSING TAPE AND BANDAGE, ADHESIVE KGX AMD-RITMED, INC./ AMD MEDICOM INC. A50044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown