BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAAS EXPANDER

    MDR report key: 4536601 · Received February 23, 2015

    Report

    Report Number
    2184045-2015-00001
    Event Type
    Injury
    Date Received
    February 23, 2015
    Report Date
    July 31, 2020
    Manufacturer
    ALLESEE ORTHODONTIC APPLIANCES
    Product Code
    DYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR REMOVED THE APPLIANCE AND THE PATIENT WAS PRESCRIBED ANTIBIOTICS FOR TREATMENT. A NEW APPLIANCE WAS FABRICATED WITH THE PALATAL ACRYLIC PLACED CLOSER TOT HE PALATE FOR PATIENT COMFORT. TO DATE, THE PATIENT IS DOING FINE AND HAS FULLY RECOVERED. THE PRODUCT WAS RETURNED AND A VISUAL EVALUATION WAS PERFORMED, YIELDING RESULTS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT A PATIENT EXPERIENCED LARGE SORES ON THE PALATE WHILE WEARING THE HAAS EXPANDER APPLIANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127574 HAAS EXPANDER RETAINER, SCREW EXPANSION, ORTHODONTIC DYJ ALLESEE ORTHODONTIC APPLIANCES 7743987

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| O