BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPORE-PAPER TAPE 1X10YDS W/DISPENSER (16-1535-0)

    MDR report key: 20687723 · Received November 13, 2024

    Report

    Report Number
    MW5162542
    Event Type
    Injury
    Date Received
    November 13, 2024
    Report Date
    November 12, 2024
    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

    PLEASE NOTE THE ATTACHED COMPLAINT INVOLVES A DEVICE ASSOCIATED WITH AN ADVERSE EVENT THAT IS NOT MANUFACTURED BY (B)(6) NORTH AMERICA. A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED (B)(6) CUSTOMER SERVICE TO REPORT THAT THE 16- 1535-0 MICROPORE-PAPER TAPE 1X10YDS W/DISPENSER TEARS HER SKIN. THE PATIENT INVOLVEMENT IS UNKNOWN HOWEVER THERE WAS NO HARM OR ADVERSE EVENT REPORTED. 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
    1169160 MICROPORE-PAPER TAPE 1X10YDS W/DISPENSER (16-1535-0) TAPE AND BANDAGE, ADHESIVE KGX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown