BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT COMFORT THIN LANCET - TWIST OFF

    MDR report key: 5018707 · Received August 12, 2015

    Report

    Report Number
    1058955-2015-00012
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    April 9, 2012
    Report Date
    August 5, 2015
    Manufacturer
    STAT MEDICAL DEVICES, INC.
    Product Code
    FMK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL COMPLAINT(B)(4), FOR THIS PRODUCT RETURN WAS CLOSED ON 05/09/2012. THIS NEW COMPLAINT(B)(4) WAS OPENED AFTER CONSULTATION WITH THE EMERGO GROUP ON THE RE-ASSESSMENT OF THE MDR SUBMISSION FOR THIS RETURNED PRODUCT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT 5 OF THE LANCETS IN A ROW "HAVE NO NEEDLES IN THEM". MR. (B)(6) EXAMINED 6 LANCETS RETURNED IN A PLASTIC ZIP LOCK BAG INDICATED ALL LANCETS HAD NEEDLES IN THEM. ADDITIONALLY 2 SEALED BOXES AND ONE OPEN BOX OF LANCETS WERE RETURNED. MR. (B)(6) EXAMINED 25 RANDOM LANCETS FROM THE OPENED BOX. ALL EXAMINED LANCETS HAD NEEDLES, NONE OF THE NEEDLES WERE BENT. ON (B)(6) 2012 MR. (B)(6) REMOVED 3 100CT BOXES OF SCU-100 LANCETS FROM INVENTORY. LOT NUMBER WAS NOT RECORDED, HOWEVER IT WAS NOTED IT WAS NOT THE SAME AS THE COMPLAINT LOT. MR. (B)(6) REMOVED THE COVERS OF ALL 300 LANCETS AND EXAMINED THEM LOOKING FOR NEEDLES. ALL LANCETS HAD NEEDLES. NONE OF THE NEEDLES WERE BENT. THE SCU LANCET IS A VERY THIN LANCET AND IS DIFFICULT TO SEE AND FELLING THE FINGERS ARE CALLUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531117 STAT COMFORT THIN LANCET - TWIST OFF TWIST OFF LANCET FMK STAT MEDICAL DEVICES, INC. SCU-100 00193

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other