BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QGRIPS

    MDR report key: 11797237 · Received May 7, 2021

    Report

    Report Number
    MW5101260
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    May 2, 2021
    Report Date
    May 6, 2021
    Manufacturer
    UNK
    Product Code
    OGQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE PURCHASED AN EAR CLEANING DEVICE CALLED QGRIPS FROM THIS WEBSITE: HTTPS://QGRIPS-OFFICIAL.ORG/ THE WEBSITE SAYS THAT THE DEVICE IS SUITABLE FOR USERS OF ALL AGES AND IS SAFE TO USE, HOWEVER, THE DEVICE DOES NOT WORK AS MARKETED I.E., THE DEVICE DOES NOT FIT INTO ADULTS EAR AND WHEN I TRIED TO USE IT FOR MY CHILD, HE SAID THAT IT IS HURTFUL. ACCORDINGLY, I BELIEVE THIS DEVICE IS A MEDICAL DEVICE, HOWEVER, IT SEEMS THAT IT IS NOT SUITABLE FOR THE INTENDED PURPOSE. I THINK THE SELLER MIGHT NOT BE COMPLIANT WITH SAFETY AND EFFECTIVENESS REQUIREMENTS FOR SUCH TYPE OF DEVICES. (B)(6). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684838 QGRIPS EAR IRRIGATION KIT OGQ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 MO