BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROLET2 LANCING DEVICE

    MDR report key: 2032286 · Received March 23, 2011

    Report

    Report Number
    1826988-2011-00157
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BAYER HEALTHCARE, LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LANCING DEVICES ARE NOT SERIALIZED OR ASSIGNED LOT NUMBERS, SO IT IS NOT POSSIBLE TO DETERMINE A MANUFACTURE DATE. LANCING DEVICES ARE ALSO NOT 510K CLEARED.

    Description of Event or Problem · 1

    A (B)(4) SALES REPRESENTATIVE CONTACTED CUSTOMER SERVICE. HE RECEIVED AN EMAIL FROM A NURSE WHO WAS USING A MICROLET2 LANCING DEVICE. THE NURSE RECEIVED A NEEDLESTICK WHILE TRYING TO REMOVE THE ENDCAP FROM THE DEVICE. A STUDENT TOOK THE DEVICE FROM THE NURSE AND ALSO RECEIVED A NEEDLESTICK BEFORE THE NURSE COULD GET THE DEVICE AWAY FROM HER. THE LANCET HAD BEEN USED. NO OTHER INFORMATION IS KNOWN AT THIS TIME. THE DEVICE IS NOT GOING TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROLET2 LANCING DEVICE NBW BAYER HEALTHCARE, LLC NOT PROVIDED NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK