BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLACKERS MTH GD GNM

    MDR report key: 11101436 · Received December 31, 2020

    Report

    Report Number
    1825660-2020-00880
    Event Type
    Malfunction
    Date Received
    December 31, 2020
    Date of Event
    December 7, 2020
    Report Date
    December 31, 2020
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    UDI-DI
    00651080651516
    PMA / PMN Number
    K094020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATED SHE HAS BEEN USING PLACKERS NIGHT GUARDS FOR AT LEAST 5 MONTHS. SHE SAID SHE SWALLOWED IT. WHEN SHE WOKE UP, IT WASN¿T IN HER MOUTH ANY MORE. IT¿S NEVER HAPPENED BEFORE. SHE HAS NO DISCOMFORT OR FEELING THAT IT IS IN HER THROAT. INFORMED CONSUMER TO LET US KNOW IF THE GUARD WAS FOUND LATER IN HER BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567813 PLACKERS MTH GD GNM MOUTHGUARD, OVER-THE-COUNTER OBR RANIR LLC MTH GD GNM 10CT 00651080651516

    Patients

    Seq Age Sex Outcome Treatment
    1