BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 1945211 · Received December 16, 2010

    Report

    Report Number
    8020030-2010-00062
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 6, 2010
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THIS EVENT BEING CONDUCTED BY LEICA MICROSYSTEMS IS CONTINUING.

    Description of Event or Problem · 1

    ON (B)(6) 2010, LEICA MICROSYSTEMS REC'D A COMPLAINT FROM (B)(6) MEDICAL CENTER REGARDING UNDER-PROCESSED TISSUE FROM TWO (2) PROTOCOLS WHICH COMMENCED ON (B)(6) 2010 AND COMPLETED ON (B)(6) 2010, 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 PELORIS

    Patients

    Seq Age Sex Outcome Treatment
    1