BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNISTICK 3 COMFORT

    MDR report key: 4297059 · Received November 13, 2014

    Report

    Report Number
    1058602-2014-00002
    Event Type
    Injury
    Date Received
    November 13, 2014
    Date of Event
    August 17, 2014
    Report Date
    November 14, 2014
    Manufacturer
    OWEN MUMFORD LTD
    Product Code
    FMK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TECHNICIAN WAS PERFORMING GLUCOSE CHECK ON PT WHEN LANCET DID NOT RETRACT AFTER USE. WHEN TECHNICIAN PICKED UP LANCET, SHE STUCK HER THUMB WITH THE USED LANCET. THE TECHNICIAN THEN TOOK OFF HER GLOVE AND RINSED SITE OFF WITH HOT WATER AS SHE PUSHED BLOOD OUT. TECHNICIAN NOTIFIED CHARGE NURSE AND NURSE OF INCIDENT. TECHNICIAN WAS SENT TO HAVE LABS DRAWN. MEDICAL QUESTIONNAIRE FILLED OUT AND RETURNED LISTED THE LABS AS THE ONLY MEDICAL TREATMENT GIVEN. MFR REF #8021764-2014-00002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733917 UNISTICK 3 COMFORT SAFETY LANCET FMK OWEN MUMFORD LTD AT 1042 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other