BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4X4,ISLAND DRESSING,STERILE 50/BX A50044

    MDR report key: 21366207 · Received February 11, 2025

    Report

    Report Number
    MW5166041
    Event Type
    Injury
    Date Received
    February 11, 2025
    Report Date
    February 7, 2025
    Manufacturer
    UNK
    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 (B)(6), CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT THAT THE ISLAND DRESSING 16-0044-0 WAS CAUSING HER TO ITCH, STATED IT MAKES HER SKIN VERY ITCH. 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
    1415635 4X4,ISLAND DRESSING,STERILE 50/BX A50044 TAPE AND BANDAGE, ADHESIVE KGX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown