BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPORE-PAPER TAPE 1X10YDS W/DISPENSER

    MDR report key: 21634266 · Received March 18, 2025

    Report

    Report Number
    MW5167783
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Report Date
    March 14, 2025
    Manufacturer
    UNK
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT THE 16- 1535-0 - MICROPORE-PAPER TAPE 1X10YDS W/DISPENSER. PATIENT MENTIONED THAT THE PAPER TAPE RIPS HER 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
    1212740 MICROPORE-PAPER TAPE 1X10YDS W/DISPENSER TAPE AND BANDAGE, ADHESIVE KGX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown