BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA CM1850UV

    MDR report key: 3839183 · Received May 15, 2014

    Report

    Report Number
    8010478-2014-00006
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 22, 2014
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IDP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THE FOLLOWING: THIS INCIDENT WAS USER RELATED, BECAUSE DURING THE REMOVING OF DEBRIS THERE WAS A KNIFE STILL IN THE UNIT, AND THE USER HAS FORGOTTEN TO REMOVE THE KNIFE BEFORE, RESPECTIVELY TO USE THE BLADE GUARD. A CUSTOMER FACING LETTER WILL BE SENT TO THE CUSTOMER WITH THE RECOMMENDATION IN FUTURE TO FOLLOW THE DESCRIPTION PROVIDED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER GOT AN INJURY TO HIS RIGHT THUMB WHILST REMOVING THE DEBRIS FROM THE UNIT. HE STATES THE THERE WAS A KNIFE STILL IN THE INSTRUMENT. HE HAS CUT HIS THUMB DUE TO THE SHARP EDGE ON THE MICROTOME BLADE. MEDICAL TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289279 LEICA CM1850UV NONE IDP LEICA BIOSYSTEMS NUSSLOCH GMBH 149185O0UVUL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other