BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA SB EINWEGKLINGEN DB80LS (1X50)

    MDR report key: 3760879 · Received April 7, 2014

    Report

    Report Number
    8010478-2014-00003
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    February 4, 2014
    Report Date
    March 10, 2014
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THE FOLLOWING: THE PACKAGE INSERT FOR THE DISPENSER WAS PROVIDED IN THE LEICA SB EINWEGKLINGEN DB80LS (1X50), AND WAS READ FROM THE CUSTOMER BEFORE THE USE OF THE DISPENSER. THE CUSTOMER HAS TRIED TO DISPOSE THE BLADES INTO THE WASTE BLADE BOX THROUGH THE HOLE ON THE BOTTOM OF THE BLADE DISPENSER, BUT CUT-RESISTANT SAFETY GLOVES WERE NOT WORE WHEN HANDLING THE BLADES AS DESCRIBED IN THE PACKAGE INSERT. THE ROOT CAUSE IS DETERMINED TO BE USER ERROR RELATED, WHERE INSTRUCTION TO WEAR CUT-RESISTANT GLOVES WAS NOT DONE. A CUSTOMER FACING LETTER WILL BE SENT TO THE CUSTOMER WITH THE RECOMMENDATION IN FUTURE TO FOLLOW THE DESCRIPTION PROVIDED IN THE PACKAGE INSERT.

    Description of Event or Problem · 1

    THE CUSTOMER GOT AN INJURY TO HER FINGER WHILST CHANGING THE BLADE ON A MICROTOME. SHE HAS CUT HER FINGER DUE TO THE SHARP EDGE ON THE MICROTOME BLADE. MEDICAL TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205727 LEICA SB EINWEGKLINGEN DB80LS (1X50) NA IEO LEICA BIOSYSTEMS NUSSLOCH GMBH 14035843488

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other