BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TK ORTHO MTB/FLS/FLS THDR/TIMR

    MDR report key: 18285867 · Received December 7, 2023

    Report

    Report Number
    1811666-2023-00001
    Event Type
    Injury
    Date Received
    December 7, 2023
    Date of Event
    November 8, 2023
    Report Date
    December 7, 2023
    Manufacturer
    RANIR
    Product Code
    NXZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ALLERGIC REACTION [HYPERSENSITIVITY]. THROAT CLOSED [THROAT TIGHTNESS]. CHEST TIGHTNESS [CHEST DISCOMFORT]. ITCHY EYES [EYE PRURITUS] . WATERY EYES [LACRIMATION INCREASED]. CASE NARRATIVE: THIS SPONTANEOUS REPORT WAS RECEIVED FROM AN UNSPECIFIED HEALTH CARE PROFESSIONAL (HCP) AT A DENTISTS OFFICE ON BEHALF OF A FEMALE CONSUMER OF UNKNOWN AGE WHO RECENTLY HAD BRACES PUT ON HER TEETH. ON 08NOV2023, THE CONSUMER USED THE ORTHODONTIC WAX FROM THE DR. FRESH ORTHODONTIC KIT ON HER BRACES. AFTER PRODUCT USE ON 08NOV2023, SHE EXPERIENCED AN ALLERGIC REACTION WITH ITCHY EYES, WATERY EYES, CHEST TIGHTNESS, AND THROAT CLOSING. SHE WAS TAKEN TO THE EMERGENCY ROOM (ER) AND EPINEPHRINE WAS ADMINISTERED AS TREATMENT. THE EVENTS RESOLVED SHORTLY AFTER TREATMENT ON (B)(6) 2023. SHE WAS PRESCRIBED AN EPI-PEN FOR FUTURE USE IF NEEDED. AS OF 08NOV2023, SHE STOPPED USE OF THE PRODUCT. THE HCP REPORTED NO CONCOMITANT MEDICATIONS, RELEVANT MEDICAL HISTORY, OR HISTORY OF ALLERGIES. ADDITIONAL DETAILS REGARDING CONSUMER DEMOGRAPHICS AND CONTACT INFORMATION WERE NOT PROVIDED BY THE HCP DUE TO HIPAA PRIVACY LAWS. THE HCP DID NOT HAVE THE PRODUCT IN QUESTION TO PROVIDE THE LOT NUMBER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221594 TK ORTHO MTB/FLS/FLS THDR/TIMR CLASS I NXZ UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening