BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGONFLY

    MDR report key: 19878205 · Received July 31, 2024

    Report

    Report Number
    3003848022-2024-00001
    Event Type
    Injury
    Date Received
    July 31, 2024
    Date of Event
    July 2, 2024
    Report Date
    July 31, 2024
    Manufacturer
    METREX RESEARCH LLC
    Product Code
    EBA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SPECIFIC INFORMATION SUCH AS AGE, WEIGHT, ETHNICITY WAS NOT PROVIDED. THE COMPLAINANT ALLEGEDLY REPORTED THAT THE HEADSTRAP WAS TOO TIGHT SUCH THAT A RASH OCCURRED WHERE THE NOSE PAD MADE CONTACT WITH. STATED THAT THE RASH STARTED IMMEDIATELY, BUT DUE TO HOW INFREQUENT THEY WERE WEARING THE LOUPES AS A STUDENT IT WOULD HAVE TIME TO HEAL IN BETWEEN. ONLY WHEN THE COMPLAINANT BEGAN WORKING AND WORE THE LOUPES FOR ABOUT FOUR DAYS A WEEK DID THIS ISSUE BEGAN TO WORSEN. THE PATIENT INITALLY DID SOME SELF-CARE, HOWEVER LATER WENT TO AN URGENT CARE AND WAS PRESCRIBED ANTIBIOTICS (AMOXICILLIN). THEY ALSO STATED THAT THE FRAME WAS TOO BIG AND WAS ONLY ABLE TO USE THE LOUPES ONLY WHEN THE HEAD STRAP WAS VERY TIGHT AND THUS THE NOSE PAD WAS PAINFULLY PRESSING INTO THE NOSE BRIDGE. DURING THE EVALUATION OF THE RETURNED LOUPES, THE LOUPES WERE ORDERED AS A MEDIUM FRAME AND THUS MADE WITH A MEDIUM FRAME UP TO SPECIFICATIONS. HOWEVER, FURTHER EVALUATION OF THE MEASUREMENTS COMPLAINANT AGAINST THE ORDERED FRAMES IT WAS NOTED THAT IT SHOULD HAVE BEEN MADE IN A SMALL SIZE. IT IS UNKNOWN WHETHER THIS WAS INTENTIONAL OR INCORRECTLY ORDERED IN A MEDIUM-SIZED FRAME. AT THIS TIME THE COMPLAINANT WAS SATISFIED WITH A FULL REFUND OF THE LOUPES AND HAS STATED THAT THEY HAVE FULLED RECOVERED.

    Description of Event or Problem · 0

    A COMPLAINANT ALLEGED THAT A RASH FORMED ON THE THEIR NOSE BRIDGE AFTER WEARING THE LOUPES. THE COMPLAINANT REPORTED THAT THE FRAME WERE TOO BIG AND WAS ONLY ABLE TO USE THE LOUPES WITH A HEADSTRAP THAT WAS VERY TIGHTLY WORN AND THUS THE NOSE PAD WAS PAINFULLY PRESSING INTO THE NOSE BRIDGE. PER THE COMPLAINANT THE RASH BEGAN IMMEDIATELY AFTER WEARING THE LOUPES, AND DUE TO HOW INFREQUENT THEY WERE WEARING THE LOUPES, IT DID NOT WORSEN OVER TIME UNTIL THEY STARTED WEARING IT FULL-TIME. CURRENTLY THE COMPLAINANT HAS NOTED THE SCARRING DUE TO THIS RASH FORMING. THEY HAD WENT TO AN URGENT CARE AND WAS GIVEN ANTIBIOTICS TO TREAT THE RASH. AT THIS TIME THE COMPLAINANT WAS SATISFIED WITH A FULL REFUND OF THE LOUPES AND HAS STATED THAT THEY HAVE FULLED RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984754 DRAGONFLY SURGICAL HEADLIGHT EBA METREX RESEARCH LLC 32455699*1*1 32455699

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Disability