BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INBRACE

    MDR report key: 11882513 · Received May 26, 2021

    Report

    Report Number
    3013023655-2021-00002
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    July 30, 2019
    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

    PER THE ORTHODONTIST'S COMMENT, THE PATIENT COULD NOT TOLERATE LINGUAL ORTHODONTIC APPLIANCE AND MAY OR MAY NOT PURSUE A DIFFERENT ORTHODONTIC OPTION.

    Description of Event or Problem · 1

    PATIENT WAS BONDED ON (B)(6) 2019 WITH THE INBRACE ORTHODONTIC APPLIANCE SYSTEM. THE PATIENT WAS SEEN 4 DAYS LATER TO RECLINCH THE END OF THE WIRE ON THE LOWER TERMINAL TEETH. THE NEXT DAY THE PATIENT RETURNED TO THE OFFICE WITH SIGNIFICANT ULCERS ON HER TONGUE AND SHE COMPLAINED OF A SORE THROAT . THE ORTHODONTIST PRESCRIBED AN ANTIBIOTIC AND REMOVED THE APPLIANCE FROM THE TERMINAL TEETH AND CLINCHED AT THE LOWER PREMOLARS (L6S). THE FOLLOWING DAY THE PATIENT REPORTED SEVERE DISCOMFORT AND REQUESTED REMOVAL OF HER BRACES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784418 INBRACE ORTHODONTIC APPLIANCE DZC SWIFT HEALTH SYSTEMS, INC 6500-11

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention