BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IHEARTEST

    MDR report key: 15249539 · Received August 17, 2022

    Report

    Report Number
    MW5111550
    Event Type
    Malfunction
    Date Received
    August 17, 2022
    Date of Event
    August 15, 2022
    Report Date
    August 15, 2022
    Manufacturer
    IHEAR MEDICAL, INC.
    Product Code
    EWO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I PURCHASED AN IHEARTEST FROM IHEARDIRECT. PER THE PRODUCT QUICK INSTALL GUIDE USERS ARE TO DOWNLOAD AND INSTALL THE APPLICATION FROM WWW.IHEARMEDICAL.COM/SIGNIN; HOWEVER, THE LINK RETURNS A 404 PAGE NOT FOUND ERROR. I WENT TO THE COMPANY WEBSITE AND COULD NOT LOCATE INFORMATION NOR ANY LABELING UPDATES THAT WOULD DIRECT ME TO BE ABLE TO USE THE PRODUCT PROPERLY. AS THE PRODUCT WAS CLEARED PER FDA K15025 AND THE PRODUCT IS REGULATED BY FDA I BELIEVE THE LACK OF CLEAR LABELING AND INFORMATION ON THE COMPANY WEBSITE CONSTITUTES ADULTERATED PRODUCT. ADDITIONALLY, THIS IS A CONCERN FROM A USER PERSPECTIVE THAT I HAVE PURCHASED A PRODUCT THAT I CAN'T USE. THERE COMPANY OFFERS VERY LITTLE IN THE WAY OF CUSTOMER SUPPORT FROM WHAT I OBSERVED ON THEIR WEBSITE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2493352 IHEARTEST AUDIOMETER EWO IHEAR MEDICAL, INC. 01-00033-001 6760

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown