BEUDAMED
    FDA Adverse Event Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 1883437 · Received October 6, 2010

    Report

    Report Number
    8020030-2010-00029
    Date Received
    October 6, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LEICA'S INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO LEICA MICROSYSTEMS OF SUBOPTIMAL TISSUE PROCESSING ON A PELORIS TISSUE PROCESSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PELORIS RAPID TISSUE PROCESSOR TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PELORIS NA

    Patients

    Seq Age Sex Outcome Treatment
    1