BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA ASP300S

    MDR report key: 3428653 · Received October 7, 2013

    Report

    Report Number
    1423337-2012-00014
    Event Type
    Injury
    Date Received
    October 7, 2013
    Date of Event
    September 9, 2013
    Report Date
    September 9, 2013
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 A LEICA FIELD SERVICE ENGINEER INFORMED LEICA MICROSYSTEMS INC THAT HE HAD CUT HIS HAND WHILE WORKING ON AN INSTRUMENT. MEDICAL TREATMENT WAS NECESSARY AS THE WOUND WAS BANDAGED IN THE EMERGENCY ROOM OF THE HOSPITAL WHERE THE FIELD SERVICE ENGINEER WAS PERFORMING SERVICE ON A LAB INSTRUMENT. THE MFR OF THIS DEVICE, LEICA BIOSYSTEMS, NUSSLOCH, IS CURRENTLY INVESTIGATING THIS EVENT. IF FURTHER INFO IS PROVIDED, A F/U REPORT WILL BE FILED. PLEASE REFERENCE MFR REPORT NUMBER 8010478-2013-0004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506738 LEICA ASP300S NONE IEO LEICA BIOSYSTEMS NUSSLOCH GMBH ASP300S

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other