BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDICHOICE 28G 1.8MM LANCET

    MDR report key: 4438679 · Received January 19, 2015

    Report

    Report Number
    1058602-2015-00001
    Event Type
    Injury
    Date Received
    January 19, 2015
    Date of Event
    November 20, 2014
    Report Date
    January 19, 2015
    Manufacturer
    OWEN MUMFORD LTD
    Product Code
    FMK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE EVENT WAS REPORTED TO HAPPEN ON (B)(6) 2014, THE EVENT WAS REPORTED TO US ON (B)(6) 2014. DURING THE PROCESS OF GATHERING INFO WE WERE NOTIFIED THAT A NURSES AID HAD BEEN PRICKED BY THE DEVICE IN USE AND ON (B)(6) 2014 A MEDICAL QUESTIONAIRE WAS SENT WITH REQUEST FOR COMPLETION AND RETURN. AFTER MULTIPLE ATTEMPTS TO RETRIEVE, THE MEDICAL QUESTIONAIRE WAS RECEIVED BY US ON (B)(6) 2015. THE MEDICAL QUESTIONAIRE STATES THAT BLOOD WORK WAS PERFORMED AND NO OTHER DETAILS ARE GIVEN. NURSES AID PERFORMED TESTING ON PT WITH DEVICE AND THE DEVICE WAS HARD TO PULL FROM THE PT'S FINGER. THE PT DID NOT SUFFER ANY INJURY. ON (B)(6) 2014 UPON TRYING TO RETRIEVE MORE INFO WE WERE INFORMED THAT THE NURSES AID WAS PRICKED BY THE DEVICE, AS IT DID NOT RETRACT. THE DEVICE WAS DISPOSED OF IN THE SHARPS CONTAINER. THE NURSES AID WAS SENT TO THE ER FOR TREATMENT. MFR REF # 8021764-2015-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43605 MEDICHOICE 28G 1.8MM LANCET UNISTIK 3 SAFETY LANCET FMK OWEN MUMFORD LTD MC 5020 J3887

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other