BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLACKERS MTH GD GNM

    MDR report key: 11464159 · Received March 11, 2021

    Report

    Report Number
    1825660-2021-00916
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Date of Event
    February 13, 2021
    Report Date
    March 11, 2021
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    UDI-DI
    00651080651516
    PMA / PMN Number
    K094020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATED: I¿VE BEEN USING THESE FOR ABOUT A WEEK. I WOKE UP THIS MORNING, AND THE GUARD WAS MISSING. I CHECKED ALL AROUND AND UNDER THE BED. NO GUARD. I¿M GUESSING I SWALLOWED IT WHILE I WAS ASLEEP. CONSUMER DIDN'T RESPOND WHETHER OR NOT HE FOUND THE GUARD IN HIS BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365028 PLACKERS MTH GD GNM MOUTHGUARD, OVER-THE-COUNTER OBR RANIR LLC MTH GD GNM 10 00651080651516

    Patients

    Seq Age Sex Outcome Treatment
    1