BEUDAMED
    FDA Adverse Event Other Summary report: N

    MONOJECT MONOLETTER

    MDR report key: 485030 · Received September 16, 2003

    Report

    Report Number
    1282497-2003-00024
    Event Type
    Other
    Date Received
    September 16, 2003
    Date of Event
    March 26, 2001
    Report Date
    April 12, 2001
    Manufacturer
    THE KENDALL CO.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO KENDALL IN 04/01 THAT ON TWO SEPARATE OCCASIONS TWO DIFFERENT NURSES HAD EXPERIENCED NEEDLESTICKS AS A RESULT OF PICKING UP USED SAFETY LANCETS WHICH HAD NOT RETRACTED. ONE INCIDENT IN 03/01, AND THE OTHER ONE IN 3/01 ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOJECT MONOLETTER SAFETY LANCET FMK THE KENDALL CO. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other