BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMD-RITMED 4X4, ISLAND DRESSING, STERILE 50/BX A50044

    MDR report key: 20941196 · Received December 12, 2024

    Report

    Report Number
    MW5163632
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    November 27, 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
    OTHER
    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 STATED THAT THE 4X4 ISLAND DRESSING BREAKS HER OUT AND GIVES HER A RASH. 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
    239051 AMD-RITMED 4X4, ISLAND DRESSING, STERILE 50/BX A50044 DRESSING, WOUND, DRUG FRO AMD-RITMED, INC 16-0044-0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown