BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLACKERS MTH GD STP GRNDNG 1CT

    MDR report key: 8894725 · Received August 14, 2019

    Report

    Report Number
    1825660-2019-00596
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Date of Event
    July 20, 2019
    Report Date
    August 14, 2019
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    PMA / PMN Number
    K094020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER (AGE (B)(6)) CALLED AND WONDERED WHAT WILL HAPPEN AS SHE SWALLOWED THE GNM ON (B)(6). SHE HAS EXTREME BLOATING (MORE THAN AVERAGE BLOATING), GONE TO THE BATHROOM A LOT, NO OTHER SYMPTOMS. SHE HAS NO PAIN BUT DOES HAVE SOME DIGESTIVE ISSUES ALREADY. SHE SCOURED HER ROOM AND BEDROOM SHEETS. THE GUARD WAS LOOSE WHEN SHE USED IT; IT WAS HER FIRST TIME TRYING THE GUARD; SHE CLAIMS SHE'S A GAGGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689405 PLACKERS MTH GD STP GRNDNG 1CT MOUTHGUARD, OVER-THE-COUNTER OBR RANIR LLC MTH GD STP GRNDNG 1CT CA 02518

    Patients

    Seq Age Sex Outcome Treatment
    1