BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELORIS II RAPID TISSUE PROCESSOR

    MDR report key: 13193711 · Received January 7, 2022

    Report

    Report Number
    1423337-2022-00001
    Event Type
    Injury
    Date Received
    January 7, 2022
    Date of Event
    December 8, 2021
    Report Date
    January 7, 2022
    Manufacturer
    LEICA BIOSYSTEMS MELBOURNE PTY. LTD
    Product Code
    IEO
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT WITH THE FOLLOWING INFORMATION: "SPECIMEN SPOTTY, THICK/THIN APPEARANCE. FIXATION ISSUE. ISSUE FOR PAST WEEK. XYLENE PROCESSING. 1 SPECIMEN UNDIAGNOSED. NO OTHER DETAILS AVAILABLE." ON (B)(6) 2021, THE COMPLAINANT PROVIDED INFORMATION TO LEICA BIOSYSTEMS THAT ONE PATIENT COULD NOT BE DIAGNOSED. THE ONE (1) PATIENT CASE WAS "NON-DIAGNOSTIC" AND THE PATIENT'S AGE AND GENDER WERE PROVIDED ON 13 DECEMBER 2021.

    Description of Event or Problem · 0

    LEICA BIOSYSTEMS RECEIVED A COMPLAINT WITH THE FOLLOWING INFORMATION: "SPECIMEN SPOTTY, THICK/THIN APPEARANCE. FIXATION ISSUE. ISSUE FOR PAST WEEK. XYLENE PROCESSING. 1 SPECIMEN UNDIAGNOSED. NO OTHER DETAILS AVAILABLE." ON (B)(6) 2021, THE COMPLAINANT PROVIDED INFORMATION TO LEICA BIOSYSTEMS THAT ONE PATIENT COULD NOT BE DIAGNOSED. THE ONE (1) PATIENT CASE WAS "NON-DIAGNOSTIC" AND THE PATIENT'S AGE AND GENDER WERE PROVIDED ON 13 DECEMBER 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793591 PELORIS II RAPID TISSUE PROCESSOR AUTOMATED TISSUE PROCESSOR IEO LEICA BIOSYSTEMS MELBOURNE PTY. LTD PELORIS II

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other