BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAMON ULTIMA

    MDR report key: 14648110 · Received June 9, 2022

    Report

    Report Number
    2016150-2022-00001
    Event Type
    Injury
    Date Received
    June 9, 2022
    Report Date
    June 1, 2022
    Manufacturer
    SDS DE MEXICO
    Product Code
    EJF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT HAD AN ALLERGIC REACTION TO BRACKET, PATIENT FACE WAS SWOLLEN AND RED, WAS ALSO VOMITING OVER A FEW DAYS, UNTIL BRACKETS WERE REMOVED FROM PATIENT ON (B)(6) 2022. ORTHODONTIST PRESCRIPTED BENADRYL. THE PATIENT HAS FULLY RECOVERED.

    Description of Event or Problem · 0

    PATIENT HAD AN ALLERGIC REACTION TO BRACKET, PATIENT FACE WAS SWOLLEN AND RED, WAS ALSO VOMITING OVER A FEW DAYS, UNTIL BRACKETS WERE REMOVED FROM PATIENT ON (B)(6) 2022. ORTHODONTIST PRESCRIPTED BENADRYL. THE PATIENT WAS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145567 DAMON ULTIMA DAMON ULTIMA EJF SDS DE MEXICO

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Other