BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLACKERS MTH GD GNM 10CT

    MDR report key: 12614712 · Received October 12, 2021

    Report

    Report Number
    1825660-2021-01014
    Event Type
    Malfunction
    Date Received
    October 12, 2021
    Date of Event
    October 4, 2021
    Report Date
    October 12, 2021
    Product Code
    OBR
    UDI-DI
    00651080651516
    PMA / PMN Number
    K094020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    I KNOW THE BOX SAYS ONE SIZE FITS ALL, BUT I WENT TO SLEEP WITH ONE IN AND WOKE UP WITH IT IN THE BACK OF MY THROAT, MY WIFE PULLED IT OUT AND I TRIED IT AGAIN. WHEN I WOKE UP THE SECOND TIME I COULD FEEL IT IN MY THROAT, I SWALLOWED IT AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518143 PLACKERS MTH GD GNM 10CT MOUTHGUARD, OVER-THE-COUNTER OBR MTH GD GNM 10CT 78500 00651080651516

    Patients

    Seq Age Sex Outcome Treatment
    1