BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 1974911 · Received January 13, 2011

    Report

    Report Number
    8020030-2011-00002
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY LTD
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT BY LEICA MICROSYSTEMS IS CONTINUING.

    Description of Event or Problem · 1

    ON (B)(6) 2010, LEICA MICROSYSTEMS RECEIVED A COMPLAINT FROM (B)(6) ACADEMY OF DERMATOPATHOLOGY REGARDING SUB-OPTIMAL PROCESSING RESULTING IN VERY DRY TISSUE FROM A PROTOCOL(S) RUN USING PELORIS TISSUE PROCESSOR SERIAL NUMBER (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1