BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMD-RITMED 4X4 ISLAND DRESSING, STERILE

    MDR report key: 20915796 · Received December 11, 2024

    Report

    Report Number
    MW5163572
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    October 21, 2024
    Report Date
    December 10, 2024
    Manufacturer
    AMD-RITMED, INC.
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT AN ISSUE AGAINST THE 4X4, ISLAND DRESSING, STERILE 50/BX A50044. THE PATIENT RONALD WAS STATING THAT 4X4 ISLAND DRESSING CAUSES RASH ON SKIN. THE PATIENT INVOLVEMENT WAS UNKNOWN, HOWEVER THERE WAS NO HARM OR ADVERSE EVENT REPORTED. 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
    2377027 AMD-RITMED 4X4 ISLAND DRESSING, STERILE DRESSING, WOUND, DRUG FRO AMD-RITMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown