BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINGERSTIX LANCET

    MDR report key: 17579 · Received November 11, 1994

    Report

    Report Number
    MW1003994
    Event Type
    Malfunction
    Date Received
    November 11, 1994
    Date of Event
    November 8, 1994
    Report Date
    November 8, 1994
    Manufacturer
    AMES DIAGNOSTICS DIV. MILES, INC.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NEEDLE PORTION OF LANCET PULLS OUT OF PLASTIC HOLDER. THIS HAS OCCURRED ON 3 DIFFERENT OCCASIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINGERSTIX LANCET FINGERSTIX LANCET FMK AMES DIAGNOSTICS DIV. MILES, INC. 9403413, 9304B11

    Patients

    Seq Age Sex Outcome Treatment
    1 *