BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KENDALL

    MDR report key: 427502 · Received November 8, 2002

    Report

    Report Number
    MW1026731
    Event Type
    Malfunction
    Date Received
    November 8, 2002
    Report Date
    November 8, 2002
    Manufacturer
    KENDALL - LTP THE LUDLOW CO LP
    Product Code
    KXN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FETAL MONITOR PAPER PREPRINTED NUMBER WAS PRINTED IN WRONG LINE SPACING. THE PROBLEM WAS DISCOVERED WHEN RPTR PRINTED DATA ON PAPER AND THAT DATA OVERLAPPED PREPRINTED #. MAY BE A "BAD" LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENDALL FETAL MONIT0R PAPER KXN KENDALL - LTP THE LUDLOW CO LP NA 72752336782892

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other