BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4X4,ISLAND DRESSING,STERILE 50/BX A50044

    MDR report key: 22931489 · Received September 2, 2025

    Report

    Report Number
    MW5175425
    Event Type
    Injury
    Date Received
    September 2, 2025
    Date of Event
    August 14, 2025
    Report Date
    August 26, 2025
    Manufacturer
    AMD-RITMED, INC./AMD MEDICOME 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 CONTACT OF A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT THAT THE ISLAND DRESSING ITCHES THE PATIENT. ACCORDING TO THE PATIENT'S CONTACT, THE BRAND OF THE ISLAND DRESSING IS RITMED. NO ADDITIONAL INFORMATION 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
    2837895 4X4,ISLAND DRESSING,STERILE 50/BX A50044 TAPE AND BANDAGE, ADHESIVE KGX AMD-RITMED, INC./AMD MEDICOME INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown