BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSIGHT PRO INFRARED VIDEO GOGGLES

    MDR report key: 18535371 · Received January 18, 2024

    Report

    Report Number
    3017632068-2024-00001
    Event Type
    Injury
    Date Received
    January 18, 2024
    Date of Event
    December 20, 2023
    Report Date
    January 18, 2024
    Manufacturer
    VESTIBULAR FIRST
    Product Code
    GWN
    UDI-DI
    00860002280738
    PMA / PMN Number
    K203082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT'S SYMPTOMS RESOLVED WITHIN 2 DAYS WITH APPLICATION OF BENEDRYL AND ORAL BENEDRYL.

    Description of Event or Problem · 0

    PATIENT CONTACTED VESTIBULAR FIRST ON 22-DEC-2023 AND REPORTED POSSIBLE ALLERGIC REACTION AROUND EYE AREA AFTER ASSESSMENT WITH INSIGHT PRO GOGGLES ON 20-DEC-2023. THE ALLERGIC REACTION WAS NOT AT THE AREAS WHERE THE GOGGLES CONTACT SKIN AT THE FOREHEAD, SIDE OF CHEEKS AND NOSE BRIDGE, BUT WAS AT THE EYE AREA THAT DOES NOT HAVE CONTACT WITH THE GOGGLES (EYELID AND BELOW THE EYE). FACILITY ROUTINELY USES MEMBER'S MARK DISINFECTING WIPES BETWEEN PATIENTS' USE. MSDS FOR MEMBER'S MARK INCLUDES ACTIVE INGREDIENTS ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE AND ALKYL DIMETHYL ETHYL BENZYL AMMONIUM CHLORIDE THAT ARE REPORTED AS IRRITANTS TO THE EYES. VESTIBULAR FIRST RECOMMENDS ONLY 70% ISOPROPYL ALCOHOL FOR DISINFECTING BETWEEN PATIENTS' USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1652865 INSIGHT PRO INFRARED VIDEO GOGGLES NYSTAGMOGRAPH GWN VESTIBULAR FIRST 00860002280738

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other