BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE DOCTOR'S NIGHTGUARD

    MDR report key: 3533893 · Received December 18, 2013

    Report

    Report Number
    2529596-2013-00009
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    November 1, 2013
    Report Date
    December 16, 2013
    Manufacturer
    PRSTIGE BRAND HOLDINGS, INC
    Product Code
    MQC
    PMA / PMN Number
    K053580
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE CONSUMER REPORTED EXPERIENCING MOUTH AND TONGUE SWELLING AND CHOKING WHILE USING THE DOCTOR'S NIGHTGUARD ADVANCE COMFORT NIGHTLY AS A DENTAL PROTECTOR ON AN UNKNOWN DATE 6 MONTHS AGO. ON AN UNKNOWN DATE THE PATIENT EXPERIENCED/DEVELOPED MOUTH AND TONGUE SWELLING AND CHOKING. THE CONSUMER STATED THAT THESE SYMPTOMS WORSENED ABOUT A MONTH AGO. THE CONSUMER STATED THAT HE "ALMOST CHOKED TO DEATH". THE CONSUMER TREATED HIS SYMPTOMS BY TAKING AN UNDISCLOSED MEDICATION PRESCRIBED BY HIS DOCTOR. AS OF (B)(6) 2013, THE MOUTH AND TONGUE SWELLING AND CHOKING HAS BEEN RESOLVED. THE CONSUMER STATED HE IS ALLERGIC TO LATEX, MORPHINE AND CODEINE. CONCOMITANT MEDICATIONS INCLUDE UNDISCLOSED HIGH BLOOD PRESSURE AND DIABETES MEDICATIONS. THE CONSUMER HAS A MEDICAL HISTORY OF HIGH BLOOD PRESSURE AND DIABETES. NO FURTHER INFORMATION WAS GIVEN AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661266 THE DOCTOR'S NIGHTGUARD NIGHTGUARD, DENTAL MQC PRSTIGE BRAND HOLDINGS, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening UNDISCLOSED HIGH BLOOD PRESSURE| DIABETES MEDICATIONS