BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAL PRINTED EXPANDER

    MDR report key: 13841262 · Received March 21, 2022

    Report

    Report Number
    2184045-2022-00001
    Event Type
    Malfunction
    Date Received
    March 21, 2022
    Date of Event
    March 17, 2022
    Report Date
    March 21, 2022
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES
    Product Code
    DYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DOCTOR REPORTED THE RIGHT LINGUAL EXTENSION BROKE OFF A METAL PRINTED EXPANDER AND THE PATIENT SWALLOWED IT. IN FOLLOW-UP WITH THE ASSISTANT, THE PATIENT WAS REFERRED TO A PEDIATRICIAN. AN X-RAY WAS RECOMMENDED, BUT NOT PURSUED AS THE COMPONENT PASSED NATURALLY THE NEXT DAY WITHOUT INCIDENT. TO DATE, THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2365864 METAL PRINTED EXPANDER RAPID PALATAL EXPANDER DYJ ALLESEE ORTHODONTIC APPLIANCES 5081115

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other