BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Q-GRIP

    MDR report key: 10061459 · Received May 14, 2020

    Report

    Report Number
    MW5094519
    Event Type
    Injury
    Date Received
    May 14, 2020
    Date of Event
    May 13, 2020
    Report Date
    May 13, 2020
    Manufacturer
    UNK
    Product Code
    OGQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HI, I USED THIS PRODUCT AND IT DAMAGED/SCRATCHED MY EARDRUM. I COULDN'T HEAR FOR A FEW DAYS AFTER USING IT. SAW MY DOCTOR WHO PRESCRIBED REST AND QUIET SOUNDS. IT DOESN'T SEEM TO BE FDA APPROVED FOR TREATMENT EVEN THOUGH IT CLAIMS TO BE. (B)(4). MY MD SAID I SCRATCHED BUT DIDN'T PERFORATE MY EARDRUM. THIS PRODUCT SHOULD BE ILLEGAL, PERIOD. (B)(4). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518425 Q-GRIP EAR IRRIGATION KIT OGQ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention