BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOGENE

    MDR report key: 14700242 · Received June 15, 2022

    Report

    Report Number
    1524213-2022-00006
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    December 27, 2021
    Report Date
    June 15, 2022
    Manufacturer
    MERIDIAN BIOSCIENCE INC.
    Product Code
    OOI
    UDI-DI
    00840733102318
    PMA / PMN Number
    K170558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE INSTRUMENT BECAME HOT (NOT BURNING BUT HAD NEVER FELT THAT WARM BEFORE). WHILE NO REPORTS OF INJURIES OR BURNS WERE MADE, MERIDIAN BIOSCIENCE HAS ELECTED TO SUBMIT THIS MDR OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910401 REVOGENE REVOGENE OOI MERIDIAN BIOSCIENCE INC. 610210 00840733102318

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown