BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNISTIK 3 COMFORT

    MDR report key: 4356266 · Received November 20, 2014

    Report

    Report Number
    1058602-2014-00003
    Event Type
    Other
    Date Received
    November 20, 2014
    Date of Event
    July 25, 2014
    Report Date
    November 20, 2014
    Manufacturer
    OWEN MUMFORD LTD
    Product Code
    FMK
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    COMPLAINT REPORTED TO OWEN MUMFORD ON (B)(6) 2014: NURSING ASSISTANT WAS DOING ROUTINE BLOOD GLUCOSE TESTING ON INPATIENT AT FACILITY WHEN SHE WAS PRICKED BY LANCET AFTER USE ON PATIENT. SHE PICKED IT UP NOT REALIZING IT HAD NOT RETRACTED INTO UNIT. NURSING ASSISTANT SENT TO ER FOR LAB WORK TO BE DRAWN ON HER AND THE PATIENT TO RULE OUT (B)(6), ETC. ALL TESTING WAS NEGATIVE. NO OTHER TREATMENT WAS GIVEN. MFR REF#: 8021767-2014-00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754739 UNISTIK 3 COMFORT SAFETY LANCET FMK OWEN MUMFORD LTD AT 1044 J3462 OR J2827

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other