BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE DOCTOR'S NIGHTGUARD

    MDR report key: 2823563 · Received September 15, 2010

    Report

    Report Number
    1719513-2010-00001
    Event Type
    Injury
    Date Received
    September 15, 2010
    Date of Event
    June 21, 2010
    Report Date
    June 25, 2010
    Manufacturer
    PRESTIGE BRANDS HOLDINGS, INC.
    Product Code
    MQC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM A CONSUMER VIA PHONE ON (B)(6) 2010. THE CONSUMER REPORTS THAT SHE HAS A HISTORY OF GRINDING HER TEETH AT NIGHT AND HAD HER DENTIST CREATE A DENTAL APPLIANCE TO HELP WITH IT. HER DENTAL APPLIANCE FROM HER DENTIST WAS DAMAGED AND NOT REPAIRABLE, SO SHE PURCHASED THIS PRODUCT. SHE FOLLOWED THE DIRECTIONS ON THE LABEL. ON HER FIRST NIGHT OF USE, SHE WOKE UP WITH TOOTH PAIN. SHE WAS SUBSEQUENTLY SEEN BY HER DENTIST WHO DETERMINED SHE HAD CRACKED A MOLAR ON EACH SIDE OF HER JAW. THE LOCATION DESCRIBED AS THE LOWER JAW, SECOND TOOTH FROM THE BACK ON EACH SIDE. THE DENTIST INDICATED THAT A CROWN WOULD REPAIR THE INJURY, BUT CALLER IS UNABLE TO AFFORD THE REPAIR AT THIS TIME. SEE SCANNED PAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THE DOCTOR'S NIGHTGUARD NONE MQC PRESTIGE BRANDS HOLDINGS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other