BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAPORE SILK TAPE

    MDR report key: 21017995 · Received December 26, 2024

    Report

    Report Number
    MW5163841
    Event Type
    Injury
    Date Received
    December 26, 2024
    Date of Event
    December 11, 2024
    Report Date
    December 20, 2024
    Manufacturer
    3M HEALTH CARE LTD.
    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 REPORTED THAT THE SILK TAPE IS TOO HARSH ON HIS SKIN. THE ADHESIVE ON THE TAPE IS TOO STRONG. WHEN THE PATIENT RIPS IT OFF IT CAUSES HIM IRRITATION AND REDNESS. 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
    80297 DURAPORE SILK TAPE TAPE AND BANDAGE, ADHESIVE KGX 3M HEALTH CARE LTD. 106100075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown