BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLACKERS MTH GD GNM

    MDR report key: 11023537 · Received December 16, 2020

    Report

    Report Number
    1825660-2020-00866
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    November 17, 2020
    Report Date
    December 16, 2020
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    UDI-DI
    00651080637060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER POSTED ON FACEBOOK: "(B)(6) HAS TMJ SO SHE WEARS THESE NIGHT GUARDS TO KEEP HER FROM GRINDING HER TEETH. MONDAY NIGHT SOMETIME SHE SWALLOWED ONE IN HER SLEEP. WE FIGURED IT WOULD JUST HAVE TO WORK ITS WAY DOWN, AND OUT POOP. THIS MORNING SHE SAID SHE FELT LIKE IT WAS IN THE SAME SPOT IN HER THROAT. SO WE WENT TO THE ER AND HAD X-RAY. THEY COULDN'T SEE IT BECAUSE IT IS PLASTIC. SO WE SAW THE GASTROENTEROLOGIST, AND THEY WANT US TO BE AT THE HOSPITAL AT 7AM TOMORROW MORNING. THEY ARE GOING TO PUT HER TO SLEEP, GO DOWN HER THROAT WITH A CAMERA, AND TRY TO FIND IT AND PULL IT OUT. (B)(6) IS CRAPPING TACKS OVER GETTING AN IV. SO IF YOU WOULD THROW A LITTLE PRAYER UP FOR HER. HELP HER NOT BE AFRAID, AND THAT THEY CAN GET IT OUT WITHOUT HAVING TO DO SURGERY." REACHED OUT TO CONSUMER, BUT DID NOT HEAR A RESPONSE BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484176 PLACKERS MTH GD GNM MOUTHGUARD, OVER-THE-COUNTER OBR RANIR LLC MTH GD GNM 14 00651080637060

    Patients

    Seq Age Sex Outcome Treatment
    1