BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INBRACE TEETH STRAIGTHENING SYSTEM

    MDR report key: 13159708 · Received January 4, 2022

    Report

    Report Number
    3013023655-2022-00001
    Event Type
    Injury
    Date Received
    January 4, 2022
    Date of Event
    December 23, 2021
    Report Date
    January 4, 2022
    Manufacturer
    SWIFT HEALTH SYSTEMS
    Product Code
    DZC
    UDI-DI
    00850018135009
    PMA / PMN Number
    K203442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT SYMPTOMS OF ITCHY MOUTH APPEAR TO BE SYMPTOMS OF AN ALLERGIC REACTION TO THE ORTHODONTIC APPLIANCE. THE SYMPTOMS SUBSIDED WITH THE USE OF ANTIHISTAMINES. THE LABELING OF 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 · 0

    IT WAS ALLEGED THAT A PATIENT HAD AN ALLERGIC REACTION TO THE INBRACE ORTHODONTIC APPLIANCE SYSTEM. THE PATIENT REPORTED THAT HER WHOLE MOUTH WAS ITCHY AND THE SYMPTOMS SUBSIDED WITH ANTIHISTAMINES. THE PATIENT REQUESTED REMOVAL OF HER BRACES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494772 INBRACE TEETH STRAIGTHENING SYSTEM ORTHODONTIC APPLIANCE DZC SWIFT HEALTH SYSTEMS 8101 00850018135009

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female Required Intervention