BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4X4,ISLAND DRESSING,STERILE 50/BX

    MDR report key: 22955795 · Received September 3, 2025

    Report

    Report Number
    MW5175594
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    August 15, 2025
    Report Date
    August 28, 2025
    Manufacturer
    RITMED
    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 (B)(6) CUSTOMER SERVICE TO REPORT THAT THE 4X4, ISLAND DRESSING, STERILE 50/BX (B)(6) MADE HER HAVE BAD SKIN IRRITATION. 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
    2132507 4X4,ISLAND DRESSING,STERILE 50/BX TAPE AND BANDAGE, ADHESIVE KGX RITMED 16-0044-0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown