BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE USE INSTRUMENT TRAY

    MDR report key: 15885709 · Received November 30, 2022

    Report

    Report Number
    15885709
    Event Type
    Malfunction
    Date Received
    November 30, 2022
    Date of Event
    May 5, 2022
    Report Date
    October 1, 2022
    Product Code
    OJV
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DYNANAIL TTC FUSION SYSTEM, LOANER TRAY FOUND WITH BIOBURDEN IN INSTRUMENTATION. TRAY NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2677092 SINGLE USE INSTRUMENT TRAY OJV

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown