BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRANSPORE-PLASTIC TRANS. TAPE 1¿X10YDS

    MDR report key: 22797223 · Received August 13, 2025

    Report

    Report Number
    MW5174469
    Event Type
    Other
    Date Received
    August 13, 2025
    Date of Event
    August 1, 2025
    Report Date
    August 11, 2025
    Manufacturer
    3M COMPANY/SOLVENTUM CORP.
    Product Code
    KGX
    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'S WIFE CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT THAT THE PLASTIC TAPE (16-1527-7) TEARS AND BURNS THE PATIENT'S SKIN. 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
    1180103 TRANSPORE-PLASTIC TRANS. TAPE 1¿X10YDS TAPE AND BANDAGE, ADHESIVE KGX 3M COMPANY/SOLVENTUM CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown