BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BILATERAL DISTAL JET

    MDR report key: 20021099 · Received August 21, 2024

    Report

    Report Number
    2184045-2024-00002
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 20, 2024
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES
    Product Code
    DYJ
    UDI-DI
    00889989088014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DOCTOR ALLEGES A BILATERAL DISTAL JET APPLIANCE CAME APART IN THE PATIENT'S MOUTH. DURING REMOVAL OF THE APPLIANCE, THE PATIENT SWALLOWED THE SPRING. THE PATIENT CONFIRMED THE SPRING PASSED NATURALLY WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2286416 BILATERAL DISTAL JET DISTAL JET DYJ ALLESEE ORTHODONTIC APPLIANCES 32632146 00889989088014

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Female Other