BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNITEK(TM) MIA MOBILE INTRAORAL ARCH

    MDR report key: 5719969 · Received June 13, 2016

    Report

    Report Number
    2020467-2016-00003
    Event Type
    Injury
    Date Received
    June 13, 2016
    Date of Event
    May 23, 2016
    Report Date
    June 1, 2016
    Manufacturer
    3M UNITEK CORPORATION
    Product Code
    DYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS EATING DINNER, HIS ORTHODONTIC PALATE EXPANDER BROKE AND A 4CM SECTION OF THE DEVICE AND WAS SWALLOWED. THE PATIENT HAD X-RAYS AND GASTROSCOPY WHICH DETERMINED THE WIRE PIECE WAS IN THE SMALL INTESTINE. IT WAS REMOVED VIA ENDOSCOPY. THE DOCTOR PRESCRIBED A PPI, OMEPRAZOLE, FOR 2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374007 UNITEK(TM) MIA MOBILE INTRAORAL ARCH INTRAORAL ORTHODONTIC PALATAL APPLIANCE DYJ 3M UNITEK CORPORATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention