BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLACKERS MTH GD GNM 16CT

    MDR report key: 9954161 · Received April 13, 2020

    Report

    Report Number
    1825660-2020-00748
    Event Type
    Malfunction
    Date Received
    April 13, 2020
    Date of Event
    February 23, 2020
    Report Date
    April 13, 2020
    Manufacturer
    RANIR LLC
    Product Code
    OBR
    UDI-DI
    00651080651523
    PMA / PMN Number
    K094020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CONSUMER STATED: "THESE WERE EASY TO USE, NO FITTING OR BOILING INVOLVED. YOU DO NEED TO ONLY USE THEM FOR 3 OR 4 DAYS, BECAUSE THEY QUICKLY BECOME TOO FLEXIBLE TO STAY WHERE YOU WANT THEM. HOWEVER, MY BIGGEST PROBLEM IS THAT OVER THE COURSE OF A FEW MONTHS (SIX MAYBE?) MY TEETH SLOWLY REALIGNED THEMSELVES, AND I WAS LEFT WITH TOOTH PAIN FROM UNEVEN PRESSURE POINTS ON THE BACK OF MY JAW. MY MOLARS JUST SORT OF REALIGNED, AND THEN THERE WAS DISCOMFORT THAT JUST GOT WORSE AND WORSE OVER A COUPLE WEEKS. A TRIP TO THE DENTIST, SOME EDGE GRINDING TO REMOVE THE PRESSURE POINTS, AND IT'S STILL TAKING TIME TO RECOVER FROM THIS." NO CONTACT INFORMATION PROVIDED, UNABLE TO RETRIEVE PRODUCT OR ASK FOR FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419284 PLACKERS MTH GD GNM 16CT MOUTHGUARD, OVER-THE-COUNTER OBR RANIR LLC MTH GD GNM 16CT 00651080651523

    Patients

    Seq Age Sex Outcome Treatment
    1