BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMD RITMED INC. ISLAND DRESSING,STERILE 50/BX

    MDR report key: 21987577 · Received May 8, 2025

    Report

    Report Number
    MW5170121
    Event Type
    Injury
    Date Received
    May 8, 2025
    Date of Event
    April 22, 2025
    Report Date
    May 6, 2025
    Manufacturer
    AMD MEDICOM INC.
    Product Code
    KGX
    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 FRESENIUS CUSTOMER SERVICE TO REPORT AN ISSUE AGAINST THE 4X4, ISLAND DRESSING, STERILE 50/BX A50044. THE PATIENT WAS ASKING IF WE HAVE A DRESSING THAT IS HYPOALLERGENIC, BUT WAS ADVISED NO, AND STATED THAT THE ISLAND DRESSING RECEIVED ON ORDER #(B)(4) DELIVERY NOTE #(B)(4) DELIVERED ON (B)(6) 2025 IS IRRITATING AND BURNING HER SKIN. THERE WAS PATIENT INVOLVEMENT, AND A 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
    346496 AMD RITMED INC. ISLAND DRESSING,STERILE 50/BX TAPE AND BANDAGE, ADHESIVE KGX AMD MEDICOM INC. A50044 12870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown