BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID PALATAL EXPANDER

    MDR report key: 7220006 · Received January 25, 2018

    Report

    Report Number
    2184045-2018-00001
    Event Type
    Malfunction
    Date Received
    January 25, 2018
    Date of Event
    December 24, 2017
    Report Date
    January 2, 2018
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES, STURTEVANT, WI
    Product Code
    DYJ
    Removal / Correction Number
    2184045-2018-00001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    CHANGE TYPE OF REPORTABLE EVENT TO MALFUNCTION.

    Additional Manufacturer Narrative · 1

    DOCTOR ALLEGED THE FACEMASK HOOK OF A RAPID PALATAL EXPANDER BROKE WHILE THE PATIENT WAS EATING AND THE PATIENT SWALLOWED THE COMPONENT. PATIENT WENT TO THE EMERGENCY ROOM ON (B)(6) 2017, AND AN ENDOSCOPY UNDER ANESTHESIA WAS PERFORMED TO REMOVE THE COMPONENT FROM THE PATIENT'S STOMACH. THE PATIENT VISITED THE ORTHODONTIST ON (B)(6) 2017, FOR REMOVAL OF THE APPLIANCE AND IS DOING FINE.

    Description of Event or Problem · 1

    DOCTOR ALLEGED THE FACEMASK HOOK OF A RAPID PALATAL EXPANDER BROKE WHILE THE PATIENT WAS EATING AND THE PATIENT SWALLOWED THE COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62650 RAPID PALATAL EXPANDER RETAINER, EXPANSION SCREW, ORTHODONTIC DYJ ALLESEE ORTHODONTIC APPLIANCES, STURTEVANT, WI 4360225

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization