BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPORE-PAPER TAPE 1X10YDS W/DISPENSER

    MDR report key: 22205510 · Received June 13, 2025

    Report

    Report Number
    MW5171483
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    May 27, 2025
    Report Date
    June 7, 2025
    Manufacturer
    UNKNOWN
    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 AND STATED THE 16-1535-0, MICROPORE-PAPER TAPE 1X10YDS W/DISPENSER IRRITATES 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
    987600 MICROPORE-PAPER TAPE 1X10YDS W/DISPENSER TAPE AND BANDAGE, ADHESIVE KGX UNKNOWN 16-1535-0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown