BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFTCLIX LANCET DEVICE

    MDR report key: 1760866 · Received July 13, 2007

    Report

    Report Number
    1823260-2007-06047
    Event Type
    Malfunction
    Date Received
    July 13, 2007
    Date of Event
    June 2, 2007
    Report Date
    July 13, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS, THE SOFTCLIX LANCET WILL NOT RETRACT, AND AS A RESULT, ACCIDENTALLY STUCK HER WITH THE NEEDLE; NO MEDICAL TREATMENT REQUIRED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFTCLIX LANCET DEVICE LANCET DEVICE - FMK FMK ROCHE DIAGNOSTICS WIR085

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR SYNTHROID - 100MCG ONCE DAILY - 30 YEARS| BELLERGAL DOSE UNK 2/DAILY - 30 YEARS| OGEN 250MG - 5/WEEK 1/DAY - 30 YEARS| PAVARINE DOSE UNK TWICE DAILY - 30 YEARS| POTASSIUM CHLORIDE 2TSP 2/DAY - 30 YEARS| LASIX AND B12 - 1/WEEK - 30 YEARS| HYDROCHLOROT 25MG - 5/WEEK - 2 YEARS