BEUDAMED
    FDA Adverse Event Summary report: N

    VNG HEARING TEST

    MDR report key: 7490115 · Received May 4, 2018

    Report

    Report Number
    MW5077024
    Date Received
    May 4, 2018
    Date of Event
    July 20, 2017
    Report Date
    May 4, 2018
    Manufacturer
    UNK
    Product Code
    GWN
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CALLER CALLED TO REPORT HAVING A HEARING TEST AND WHEN THE ADMIN OF THE TEST PLACED THE NOZZLE OF THE DEVICE INTO HIS EAR, HE HEARD A LOUD SOUND THAT GAVE HIM DISCOMFORT, PAIN, AND PRESSURE. HE STATES THAT IT WAS SO PAINFUL THAT HE PUSHED THE HAND AWAY OF THE ADMIN. THE REPORTER STATES THAT THE ADMIN HAD AN OPTION OF USING A 2-WAY NOZZLE AND SHE DIDN'T. HE BELIEVES THAT IT SHOULDN'T HAVE BEEN AN OPTION FOR HER TO USE A 1-WAY NOZZLE AND THAT THE 2-WAY NOZZLE IS THE BETTER COMPONENT FOR THIS PROCEDURE. HE STATES THAT THIS SHOULD HAVE BEEN MANDATED BY THE MFR OF THIS TYPE OF TEST SO THAT PEOPLE WILL NOT IN CHRONIC PAIN, AND THE FEELING OF PRESSURE LIKE HAS FELT IN HIS EARS FOR TEN MONTHS NOW. REPORTER STATES THAT HE HAS FOUND THREE OTHER PEOPLE ON THE INTERNET THAT HAD THE SAME THING HAPPEN TO THEM AND THAT HE PLANS TO REACH OUT TO THEM SO, THEY CAN TOO FILE A COMPLAINT WITH THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331854 VNG HEARING TEST NYSTAGMOGRAPHY SYSTEM (VNG) GWN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other