BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISLAND DRESSING, 4" X 4 ¿ 50/BX

    MDR report key: 22796978 · Received August 13, 2025

    Report

    Report Number
    MW5174456
    Event Type
    Injury
    Date Received
    August 13, 2025
    Report Date
    August 7, 2025
    Manufacturer
    AMD-RITMED / 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

    PLEASE NOTE THE ATTACHED COMPLAINT INVOLVES A DEVICE ASSOCIATED WITH AN ADVERSE EVENT THAT IS NOT MANUFACTURED BY (B)(6). A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT THAT THE 4X4,ISLAND DRESSING,STERILE 50/BX A50044 MADE BY RITMED RIPS HER SKIN OFF WHEN REMOVING IT. NO FURTHER INFORMATION WAS PROVIDED. 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
    782279 ISLAND DRESSING, 4" X 4 ¿ 50/BX TAPE AND BANDAGE, ADHESIVE KGX AMD-RITMED / AMD MEDICOM INC. A50044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown