BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLACKERS MTH GD GNM

    MDR report key: 10020320 · Received May 4, 2020

    Report

    Report Number
    1825660-2020-00756
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    April 4, 2020
    Report Date
    May 4, 2020
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    UDI-DI
    5108090651
    PMA / PMN Number
    K094020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATED, "I SWALLOWED YOUR GRIND NO MORE GUARD IN MY SLEEP AND IT'S BEEN LODGED IN MY ESOPHAGUS FOR TWO DAYS... I WOKE UP THREE DAYS AGO CHOKING WITH A PAIN IN MY CHEST, WITH COLD SWEATS... I REALIZED IT WAS A WEIRD AND STABBING PAIN, AND IN MY ESOPHAGUS AND THAT MY GUARD WAS NOT IN MY MOUTH, OR ON MY BED. I THOUGHT I WAS LOSING IT AND WENT BACK TO SLEEP. WOKE UP IN THE MORNING WITH THE SAME PAIN IN MY CHEST, AND ANYTIME I ATE THAT DAY I COULD FEEL IT MOVE UP AND DOWN. THE NEXT MORNING I WAS ADVISED BY MY DOCTOR TO GO TO THE ER. THEY X-RAYED ME, BUT AS IT'S SILICONE, THEY ALSO HAD ME HOLD ANOTHER GUARD WHILE BEING X-RAYED TO SEE IF IT WOULD SHOW UP. IT DID, THEY BOTH DID, ONE AS A SHADOW IN THE CORNER OF THE X-RAY AND ONE RIGHT BETWEEN MY BREAST BONE IN MY ESOPHAGUS. THE ER HAD TO CALL IN A SEPARATE ON CALL ENT TEAM TO COME PERFORM AN ENDOSCOPY. THEY SAID THEY WERE UNABLE TO GRAB IT AS IT SLID DOWN INTO MY STOMACH BUT THAT I SHOULD EXPECT THE PLEASURE OF 'PASSING' IT IN 2-10 DAYS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483551 PLACKERS MTH GD GNM MOUTHGUARD, OVER-THE-COUNTER OBR RANIR LLC MTH GD GNM 10 CA 5108090651

    Patients

    Seq Age Sex Outcome Treatment
    1