BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLACKERS MTH GD GNM 16CT

    MDR report key: 12418211 · Received September 2, 2021

    Report

    Report Number
    1825660-2021-00999
    Event Type
    Malfunction
    Date Received
    September 2, 2021
    Date of Event
    August 13, 2021
    Report Date
    September 2, 2021
    Product Code
    OBR
    UDI-DI
    5108065152
    PMA / PMN Number
    K094020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    HELLO, MY BOYFRIEND HAS RECENTLY BOUGHT A DENTAL GUARD AND IT IS ONE OF THE SMALL SOFT DENTAL GUARDS. WHILE WAKING UP THIS MORNING HE SEEMED TO NOT BE ABLE TO FIND, WE FLIPPED THE ROOM UPSIDE DOWN JUST LOOKING FOR IT. WE BOTH BELIEVE THAT HE HAS SWALLOWED THE GRIND NO MORE, AND WHILE HE IS IN NO PAIN I JUST WANTED TO KNOW WHAT WOULD BE THE BEST OPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315842 PLACKERS MTH GD GNM 16CT MOUTHGUARD, OVER-THE-COUNTER OBR MTH GD GNM 16CT 112819 5108065152

    Patients

    Seq Age Sex Outcome Treatment
    1