BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMD RITMED INC DRESSING (TRANSPARENT / ISLAND) - ISLAND DRESSING, 4" X 4" WITH 2

    MDR report key: 21892311 · Received April 23, 2025

    Report

    Report Number
    MW5169469
    Event Type
    Injury
    Date Received
    April 23, 2025
    Report Date
    April 21, 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

    PLEASE NOTE THE 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 A COMPLAINT REGARDING THE 4X4, ISLAND DRESSING, STERILE 50/BX A50044. PATIENT CALLED TO STATE THE ADHESIVE ON THE ISLAND DRESSING MADE BY RIT MED (A50044) AND PETRO PACIFICA MANUFACTURER IS TOO STRONG AND IS TEARING THE PATIENT'S SKIN. NO LOT/EXP DATE ON BOXES. PATIENT FIRST GOT THESE MANUFACTURERS 2/10. THE ONE THAT THE PATIENT LIKES ARE #44258 MADE BY MEDICAL ACTION. THE PATIENT INVOLVEMENT IS 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
    560656 AMD RITMED INC DRESSING (TRANSPARENT / ISLAND) - ISLAND DRESSING, 4" X 4" WITH 2 TAPE AND BANDAGE, ADHESIVE KGX AMD MEDICOM INC. A50044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown