BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFT TACT/SOF-SENSE BLOOD GLUCOSE METER

    MDR report key: 392797 · Received April 30, 2002

    Report

    Report Number
    1220459-2002-00063
    Event Type
    Other
    Date Received
    April 30, 2002
    Date of Event
    April 2, 2002
    Report Date
    April 30, 2002
    Manufacturer
    MEDISENSE, INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MEDISENSE SALES REP REPORTEDLY WAS DEMONSTRATING A SOFT-TACT/SOF-SENSE METER SALES REP ACCIDENTLY LANCED THE PALM OF ONE GLOVED HAND WITH A CONTAMINATED LANCET AS SALES REP WAS ATTEMPTING TO REMOVE THE CAP OF THE DEVICE. 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
    1 SOFT TACT/SOF-SENSE BLOOD GLUCOSE METER BLOOD GLUCOSE METER LFR MEDISENSE, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other