BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNISTIK 3 COMFORT

    MDR report key: 4449995 · Received January 21, 2015

    Report

    Report Number
    1058602-2015-00003
    Event Type
    Injury
    Date Received
    January 21, 2015
    Date of Event
    November 21, 2014
    Report Date
    January 21, 2015
    Manufacturer
    OWEN MUMFORD LTD
    Product Code
    FMK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED TO HAPPEN ON (B)(6) 2014, THE EVENT WAS FIRST REPORTED TO US ON (B)(6) 2014. DURING THE PROCESS OF GATHERING INFO WE WERE NOTIFIED ON (B)(6) 2015 THAT A NURSES AID HAD BEEN PRICKED BY THE DEVICE IN USE. A MEDICAL QUESTIONNAIRE WAS SENT WITH REQUEST FOR COMPLETION AND RETURN, AFTER MULTIPLE ATTEMPTS TO RETRIEVE, THE MEDICAL QUESTIONNAIRE WAS RECEIVED BY US ON (B)(4) 2015. THE MEDICAL QUESTIONNAIRE STATES THAT BLOOD WORK WAS PERFORMED AND NO OTHER DETAILS ARE GIVEN. NURSES AID TOOK PATIENT BLOOD SUGAR AND PUT THE LANCET ON THE TABLE, WHEN SHE PICKED IT UP TO DISPOSE OF THE LANCET SHE WAS STUCK IN THE LEFT THUMB AS THE NEEDLE DID NOT RETRACT. MFR #8021764-2015-00003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47510 UNISTIK 3 COMFORT SAFETY LANCET FMK OWEN MUMFORD LTD AT 1044 J3639

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other