BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAPORE SILK TAPE 1X10 YDS

    MDR report key: 19352972 · Received May 17, 2024

    Report

    Report Number
    MW5155128
    Event Type
    Injury
    Date Received
    May 17, 2024
    Date of Event
    May 7, 2024
    Report Date
    May 16, 2024
    Manufacturer
    3M HEALTH CARE LTD.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT (B)(6) CONTACTED FRESENIUS CUSTOMER SERVICE TO REPORT THAT THE SILK TAPE, THAT HE RECEIVED WITH HIS FIRST DELIVERY, IRRITATES HIS SKIN. HE STATED THAT THE TAPE IS PAINFUL TO REMOVE. 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
    583427 DURAPORE SILK TAPE 1X10 YDS TAPE AND BANDAGE, ADHESIVE KGX 3M HEALTH CARE LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown