BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAPORE SILK TAPE

    MDR report key: 21398861 · Received February 18, 2025

    Report

    Report Number
    MW5166336
    Event Type
    Injury
    Date Received
    February 18, 2025
    Report Date
    February 12, 2025
    Manufacturer
    3M HEALTH CARE LTD. / 3M COMPANY
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    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. THE PATIENT ALSO STATED THAT THE DURAPORE SILK TAPE 16-3616-6 WAS GIVING HER A RASH AND IT BURNS THE SKIN AND WAS CAUSING HER DISCOMFORT. 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
    1387913 DURAPORE SILK TAPE TAPE AND BANDAGE, ADHESIVE KGX 3M HEALTH CARE LTD. / 3M COMPANY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown