BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA CM1850UV

    MDR report key: 3876187 · Received May 16, 2014

    Report

    Report Number
    1423337-2014-00004
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 22, 2014
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IDP
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, LEICA BIOSYSTEMS WAS NOTIFIED THAT A USER INJURED HIS RIGHT THUMB WHILE REMOVING DEBRIS FROM THE INSTRUMENT. THE CUSTOMER STATES THAT A KNIFE WAS STILL IN THE INSTRUMENT AND HIS THUMB WAS CUT DUE TO THE SHARP EDGE ON THE BLADE. MEDICAL TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294005 LEICA CM1850UV NONE IDP LEICA BIOSYSTEMS NUSSLOCH GMBH 1491850UVUL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other