BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS RAPID TISSUE PROCESSOR

    MDR report key: 3934654 · Received June 25, 2014

    Report

    Report Number
    8020030-2014-00022
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    LEICA BIOSYSTEMS MELBORNE
    Product Code
    IEO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, LEICA MICROSYSTEMS RECEIVED INFORMATION FROM THE LABORATORY REGARDING THE STATUS OF THE TISSUE SAMPLES FROM WHICH SUB-OPTIMAL TISSUE PROCESSING WAS REPORTED. THE INFORMATION RECEIVED STATED THAT RE-BIOPSY OF NINE (9) OF THESE PATIENTS. REFER TO MFR. REPORT# 8020030-2014-00021 SUBMITTED FOR PELORIS II TISSUE PROCESSOR AND 8020030-2014-00023, 8020030-2014-00024, 8020030-2014-00025, 8020030-2014-00026, 8020030-2014-00027, 8020030-2014-00028, 8020030-2014-00029, 8020030-2014-00030 FOR SPECIFIC DETAILS OF THE OTHER PATIENTS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371146 PELORIS RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBORNE PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention