BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES ELLIPTIC

    MDR report key: 3316819 · Received August 29, 2013

    Report

    Report Number
    3003848022-2013-00009
    Event Type
    Injury
    Date Received
    August 29, 2013
    Report Date
    August 19, 2013
    Manufacturer
    METREX RESEARCH, LLC
    Product Code
    FSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR USED A PRESCRIPTION CORTISONE OINTMENT FOR TREATMENT OF THE SYMPTOMS. THE SYMPTOMS SUBSIDED AFTER APPROXIMATELY ONE (1) WEEK. TO DATE, THE DOCTOR HAS FULLY RECOVERED AND IS DOING FINE. A VISUAL AND PHYSICAL EVALUATION PERFORMED ON THE ACTUAL DEVICE REVEALED THAT THE PAINT HAD WORN AWAY FROM THE FRAMES.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT HE HAD DEVELOPED AN ALLERGIC REACTION IN THE FORM OF REDNESS AND SWELLING AROUND THE EYES AFTER WEARING THE HIRES ELLIPTIC DENTAL LOUPE. THE DOCTOR REPORTED THAT OVER THE YEARS OF USE, THE PAINT LAYER HAD WORN AWAY FROM THE FRAMES OF THE HIRES ELLIPTIC LOUPE; THEREFORE, THE METAL OF THE FRAMES WAS CONTACTING HIS SKIN DIRECTLY. THE DOCTOR REPORTED THAT HE HAD BEGUN REACTING TO THE FRAMES WHEN THE PAINT LAYER HAD WORN AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426125 HIRES ELLIPTIC SURGICAL LOUPE FSP METREX RESEARCH, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other| R