BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEICA ASP300

    MDR report key: 3193547 · Received June 25, 2013

    Report

    Report Number
    8010478-2013-00003
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 31, 2013
    Manufacturer
    LEICA BIOSYSTEMS NUSSLOCH GMBH
    Product Code
    IEO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION OF THE EVENT IS CURRENTLY UNDERWAY AND THE CONCLUSION FROM THE INVESTIGATION WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER PROCESSING, THE TISSUE SAMPLES HAD BEEN SUB-OPTIMALLY PROCESSED. TWO PTS REQUIRED RE-BIOPSY, BECAUSE THE SPECIMENS COULD NOT BE DIAGNOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289018 LEICA ASP300 NONE IEO LEICA BIOSYSTEMS NUSSLOCH GMBH ASP300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other