BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMD-RITMED 4X4, ISLAND DRESSING

    MDR report key: 21244468 · Received January 27, 2025

    Report

    Report Number
    MW5165313
    Event Type
    Injury
    Date Received
    January 27, 2025
    Date of Event
    January 14, 2025
    Report Date
    January 20, 2025
    Manufacturer
    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) PATIENT CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT THAT HE IS ALLERGIC TO THE ISLAND DRESSINGS. HE DOES NOT REMEMBER WHEN THE FIRST REACTION OCCURRED OR WHEN WAS HIS LAST REACTION. WHEN HE USES THEM, HIS SKIN BECOMES ITCHY AND SWOLLEN. 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
    1501999 AMD-RITMED 4X4, ISLAND DRESSING DRESSING, WOUND, DRUG FRO AMD MEDICOM INC. 9611

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown