BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGONFLY

    MDR report key: 22039504 · Received May 16, 2025

    Report

    Report Number
    3003848022-2025-00001
    Event Type
    Injury
    Date Received
    May 16, 2025
    Report Date
    May 16, 2025
    Manufacturer
    METREX RESEARCH LLC DBA ORASCOPTIC
    Product Code
    EBA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC INFORMATION SUCH AS AGE, SEX, WEIGHT, AND ETHNICITY WERE NOT PROVIDED. THE COMPLAINANT ALLEGED THAT THE LOUPES WERE CAUSING AN ALLERGIC REACTION. THEY STATED THAT THE ALLERGIC REACTION BEGAN A COUPLE MONTHS AGO AND HAS ONLY SINCE GOTTEN WORSE. THE COMPLAINANT STATED THEY HAD AN PRE-EXISTING CONDITION-- AN ALLERGY TO NICKEL. THEY SOUGHT MEDICAL ATTENTION WITH A DERMATOLOGIST WHO DIAGNOSED IT AS AN ALLERGIC REACTION AND PRESCRIBED THEM HYDROCORTISONE.

    Description of Event or Problem · 0

    A COMPLAINANT ALLEGED THAT THEY HAD AN ALLERGIC REACTION TO THE LOUPES. THE COMPLAINANT REPORTED THAT THE ALLERGIC REACTION BEGAN A COUPLE MONTHS AGO WHERE IT ONLY HAS BEEN GETTING WORSE. IT WAS REPORTED THAT THE COMPLAINANT HAS A PRE-EXISTING CONDITION: AN ALLERGY TO NICKEL AND HAD SOUGHT MEDICAL ATTENTION WITH A DERMATOLOGIST WHERE THE DERMATOLOGIST DIAGNOSED IT AS AN ALLERGIC REACTION AND PRESCRIBED THE COMPLAINANT WITH HYDROCORTISONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2050206 DRAGONFLY SURGICAL HEADLIGHT EBA METREX RESEARCH LLC DBA ORASCOPTIC 32866698*1*1 32866698

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention