BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFT TACT/SOF-SENSE BLOOD GLUCOSE METER

    MDR report key: 354015 · Received September 26, 2001

    Report

    Report Number
    1220459-2001-00138
    Event Type
    Other
    Date Received
    September 26, 2001
    Date of Event
    August 29, 2001
    Report Date
    September 25, 2001
    Manufacturer
    MEDISENSE, INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MEDISENSE SALES REP REPORTEDLY WAS DEMONSTRATING A SOFT-TACT/SOF-SENSE METER AND ACCIDENTLY CUT FINGER WITH THE CONTAMINATED LANCET AS SALES REP WAS ATTEMPTING TO REMOVE THE DISPOSABLE NEEDLE PORTION. THE SALES REP WAS ADVISED TO FOLLOW-UP WITH PRIMARY CARE PHYSICIAN OR LOCAL HOSP IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43520 SOFT TACT/SOF-SENSE BLOOD GLUCOSE METER BLOOD GLUCOSE METER LFR MEDISENSE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other