BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFT CUSTOM NIGHT GUARD

    MDR report key: 1843444 · Received September 21, 2010

    Report

    Report Number
    MW5017538
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    July 20, 2010
    Report Date
    September 21, 2010
    Manufacturer
    PRO WHITE TEETH / PRO-ACTIVE LABS
    Product Code
    MQC
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PAINFUL BLISTERS INSIDE THE MOUTH AFTER ONE NIGHT OF USING A NIGHT GUARD. DOSE OR AMOUNT: 1 NIGHT GUARD; FREQUENCY: 1 TIME USE; ROUTE: PO. DATES OF USE: (B)(6)2010 - (B)(6)2010. DIAGNOSIS OR REASON FOR USE: BRUXISM. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. HTTP://PROWHITETEETH.COM/SOFT-NIGHT-GUARD-P-9.HTML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFT CUSTOM NIGHT GUARD NIGHT GUARD MQC PRO WHITE TEETH / PRO-ACTIVE LABS NGL89

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR NIGHT GUARD CLEANER