BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALACOS MV+G

    MDR report key: 15923535 · Received December 6, 2022

    Report

    Report Number
    15923535
    Event Type
    Malfunction
    Date Received
    December 6, 2022
    Date of Event
    November 7, 2022
    Report Date
    November 30, 2022
    Manufacturer
    HERAEUS MEDICAL GMBH
    Product Code
    JDZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    LIQUID ACTIVATOR DIDNT TRANSFER TO CEMENT POWDER WITHIN ENCLOSED SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742588 PALACOS MV+G MIXER, CEMENT, FOR CLINICAL USE JDZ HERAEUS MEDICAL GMBH MV+G PRO 80 9009331615

    Patients

    Seq Age Sex Outcome Treatment
    1 29565 DA Unknown