BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROLET2 LANCING DEVICE

    MDR report key: 2001721 · Received February 22, 2011

    Report

    Report Number
    1826988-2011-00101
    Event Type
    Injury
    Date Received
    February 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 11, 2011
    Manufacturer
    BAYER HEALTHCARE LLC
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    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 SCHOOL NURSE ALLEGED THAT SHE REC'D AN ACCIDENTAL NEEDLESTICK FROM A USED LANCET WHILE TRYING TO EJECT IT FROM THE MICROLET2 LANCING DEVICE. NO OTHER INFO WAS PROVIDED ABOUT THE INCIDENT. THE LANCING DEVICE IS TO BE RETURNED FOR EVAL. A NEW LANCING DEVICE WAS SENT TO THE NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROLET2 LANCING DEVICE NBW BAYER HEALTHCARE LLC 6606 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK