BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 8426896 · Received March 16, 2019

    Report

    Report Number
    1423337-2019-00005
    Event Type
    Injury
    Date Received
    March 16, 2019
    Date of Event
    February 15, 2019
    Report Date
    March 15, 2019
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    LEICA BIOSYSTEMS RECEIVED A TISSUE PROCESSING COMPLAINT. ON (B)(6) 2019, LEICA BIOSYSTEMS RECEIVED INFORMATION FROM THE LABORATORY THAT TISSUE WAS NON-DIAGNOSTIC AND THAT RE-BIOPSY WAS RECOMMENDED. THE UNDIAGNOSABLE CASE IS FROM A (B)(6) YEAR OLD MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220076 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other