BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPT-IT

    MDR report key: 7937709 · Received October 5, 2018

    Report

    Report Number
    7937709
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Date of Event
    September 29, 2017
    Report Date
    June 12, 2018
    Manufacturer
    QFIX
    Product Code
    IYE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LEARNED THAT ITEM INVOLVED IN AN INCIDENT WAS FROM THE USE OF PELLETS FORMED INTO A BITE BLOCK, THAT BECAUSE NOT USED AS DIRECTED, ADHERED TO A PATIENT'S DENTITION AND A DENTIST HAD TO REMOVE (PREVIOUSLY THOUGHT A THERMOPLASTIC MASK HAD ADHERED, BUT THAT WAS NOT CORRECT-FDA NOTIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778821 ADAPT-IT ACCELERATOR, LINEAR, MEDICAL IYE QFIX RT-7003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other