BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 2121728 · Received June 2, 2011

    Report

    Report Number
    1423337-2011-00001
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 29, 2011
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, LEICA MICROSYSTEMS RECEIVED A COMPLAINT FROM THE (B)(6) REGARDING SUB-OPTIMAL PROCESSING OF FIVE BONE MARROW BIOPSIES FROM A PROTOCOL WHICH COMMENCED ON (B)(6) 2011, USING THE PELORIS TISSUE PROCESSOR SERIAL NUMBER (B)(4). LEICA WAS ADVISED ON (B)(6) THAT THE SPECIMENS WERE UNDIAGNOSABLE.

    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 Other