BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 3095996 · Received May 2, 2013

    Report

    Report Number
    1423337-2013-00008
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    LEICA MICROSYSTEMS, INC.
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 LEICA BIOSYSTEMS RECEIVED INFORMATION FROM A CUSTOMER WHILE ON SITE PERFORMING APPLICATION SUPPORT THAT A REBIOPSY OF ONE SPECIMEN WAS REQUIRED. ON (B)(6) 2013 LEICA BIOSYSTEMS RECEIVED INFORMATION FROM THE CUSTOMER THAT A STOMACH BIOPSY HAD TO BE RECOLLECTED. IF FURTHER PATIENT IDENTIFIER INFORMATION IS OBTAINED A FOLLOW UP REPORT WILL BE SUBMITTED. PLEASE REFER TO MFR. REPORT # 8020030-2013-00032 FOR INFORMATION RELATED TO THE INSTRUMENT AND INITIAL COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191978 PELORIS RAPID TISSUE PROCESSOR TISSUE PROCESSOR IEO LEICA MICROSYSTEMS, INC. PELORIS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention