BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRE ICE

    MDR report key: 4600763 · Received March 13, 2015

    Report

    Report Number
    2016150-2015-00007
    Event Type
    Injury
    Date Received
    March 13, 2015
    Report Date
    February 16, 2015
    Manufacturer
    ORMCO CORPORATION
    Product Code
    ECQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SPECIFIC PATIENT INFORMATION WITH REGARD TO GENDER, AGE AND WEIGHT WAS NOT PROVIDED. THE PATIENT WAS PRESCRIBED PAIN MEDICATION AND MEDICATION FOR THE MUCOSA. TO DATE, THE PATIENT HAS FULLY RECOVERED AND IS DOING FINE. THE DEVICE INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED; THEREFORE, NO EVALUATION CAN BE CONDUCTED.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT EIGHT (8) PATIENTS HAD EXPERIENCED MUCOSA DAMAGE AFTER WEARING THE INSPIRE ICE BRACKET. THIS IS THE FOURTH OF EIGHT (8) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174361 INSPIRE ICE ORTHODONTIC BRACKET ECQ ORMCO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R