BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INBRACE

    MDR report key: 11882151 · Received May 25, 2021

    Report

    Report Number
    3013023655-2021-00001
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    January 23, 2020
    Report Date
    May 25, 2021
    Manufacturer
    SWIFT HEALTH SYSTEMS, INC
    Product Code
    DZC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SYMPTOMS OF TONGUE SORENESS, THROAT PAIN AND SWELLING APPEAR TO BE SYMPTOMS OF AN ALLERGIC REACTION TO THE ORTHODONTIC APPLIANCE. ONCE THE APPLIANCE WAS REMOVED, THE SYMPTOMS SUBSIDED. THE LABELLING FOR THE DEVICE WARNS THAT THE PRODUCT CONTAINS NICKEL AND CHROMIUM AND SHOULD NOT BE USED FOR INDIVIDUALS WITH KNOWN ALLERGIC SENSITIVITY TO THESE METALS.

    Description of Event or Problem · 1

    PATIENT WAS BONDED ON (B)(6) 2020 WITH THE INBRACE ORTHODONTIC APPLIANCE SYSTEM. ON (B)(6) 2020, THE PATIENT RETURNED TO THE OFFICE AND REPORTED TONGUE SORENESS, THROAT PAIN AND SWELLING. THE ORTHODONTIST PRESCRIBED AN ANTIBIOTIC AND MOUTH RINSE, BUT HER SYMPTOMS WORSENED. THE PATIENT REQUESTED REMOVAL OF HER BRACES THAT EVENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771843 INBRACE ORTHODONTIC APPLIANCE DZC SWIFT HEALTH SYSTEMS, INC 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention