BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMD-RITMED 4X4, ISLAND DRESSING, STERILE 50/BX

    MDR report key: 22131092 · Received June 2, 2025

    Report

    Report Number
    MW5170995
    Event Type
    Injury
    Date Received
    June 2, 2025
    Date of Event
    May 15, 2025
    Report Date
    May 28, 2025
    Manufacturer
    AMD-RITMED/ AMD MEDICOM INC.
    Product Code
    FRO
    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 THE 16-0044-0 - 4X4, ISLAND DRESSING, STERILE 50/BX A50044. THE PATIENT STATED SHE HAD A SMALL REACTION TO THE ISLAND DRESSING AND WILL USE PAPER TAPE AND GAUZE AS HER REGISTERED NURSE SUGGESTED. THANK YOU. 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
    361617 AMD-RITMED 4X4, ISLAND DRESSING, STERILE 50/BX DRESSING, WOUND, DRUG FRO AMD-RITMED/ AMD MEDICOM INC. A50044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown