BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANCET

    MDR report key: 1060565 · Received June 17, 2008

    Report

    Report Number
    MW5007265
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 17, 2008
    Manufacturer
    LIBERTY MEDICAL
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER REPORTS THAT HER LANCET DEVICE SHOULD BE REDESIGNED. REPORTER STATES THAT WHEN SHE REMOVES THE CAP ON THE LANCET AND REPLACE THE CAP PER INSTRUCTIONS, THERE COULD BE A POTENTIAL FOR A NEEDLE STICK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANCET SPECIALITY MED SUPPLY/LIBERTY MEDICAL SUPPLY FMK LIBERTY MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR