BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDI-LANCE

    MDR report key: 31734 · Received April 4, 1996

    Report

    Report Number
    MW4001141
    Event Type
    Malfunction
    Date Received
    April 4, 1996
    Report Date
    February 26, 1996
    Manufacturer
    MEDICORE, INC.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    LANCETS IN 2 SEPARATE BOXES HAVE 2 DIFFERENT SIZE BASES. LANCETS FROM ONE BOX WILL FIT INTO FINGER PRICKING DEVICE; LANCETS FROM ANOTHER BOX WILL NOT FIT INTO THE DEVICE. ALTHOUGH THE LANCETS DIFFER, EACH BOX BEARS THE SAME LOG NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDI-LANCE STERILE BLOOD LANCET FMK MEDICORE, INC. K14095

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO