BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLACKERS MTH GD GNM

    MDR report key: 8386369 · Received March 4, 2019

    Report

    Report Number
    1825660-2019-00517
    Event Type
    Injury
    Date Received
    March 4, 2019
    Date of Event
    February 8, 2019
    Report Date
    March 4, 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 STATED SHE HAD BEEN A LONG TIME CONSUMER OF YOUR GRIND NO MORE NIGHT GUARDS. SHE ENJOYED USING THE GUARD AS IT'S SO MUCH SMALLER AND LIGHTER THAN THE BIG, FULL-COVERAGE NIGHT GUARD. CONSUMER STATED "IT WASN'T UNTIL RECENTLY THAT I LEARNED I NOW HAVE A MALOCCLUSION AS A RESULT OF LONG-TIME USE OF GRIND NO MORE. MY BACK TEETH NO LONGER TOUCH AT EXACTLY WHERE THE BITE PLATES TOUCH THE TEETH, THEREBY CAUSING MY FRONT TEETH TO WEAR AWAY AND CAUSE CONTINUOUS CHIPPING OF THAT FRONT-TOOTH BONDING I HAVE. AT THE SUGGESTION OF MY DENTIST, I HAD AN ORTHODONTIC CONSULTATION AND 12-18 MONTHS WORTH OF TREATMENT TO FIX MY PROBLEM. I'M SAD THAT I WASN'T AWARE THAT LONG-TERM USE OF YOUR PRODUCT WOULD CAUSE SUCH MAJOR ISSUES. SHE USED THE GUARDS FOR 5 YEARS (IT WAS NOT CLEAR IF SHE WAS USING THE SAME EXACT GUARD, BUT IT'S BELIEVED THAT SHE WAS USING SEVERAL GUARDS OVER THE 5 YEARS). DIRECTIONS STATE NOT TO USE THE PRODUCT MORE THAN 3 MONTHS FROM INITIAL USE WITHOUT CONSULTING YOUR DENTIST AND TO CONTINUE SEEING YOUR DENTIST EVERY SIX MONTHS THEREAFTER WHILE USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180912 PLACKERS MTH GD GNM MOUTHGUARD, OVER-THE-COUNTER OBR RANIR LLC MTH GD GNM 10CT

    Patients

    Seq Age Sex Outcome Treatment
    1