BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZQUIET

    MDR report key: 1981169 · Received February 2, 2011

    Report

    Report Number
    MW5019272
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 2, 2011
    Manufacturer
    SLEEPING WELL, LLC
    Product Code
    LRK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HI - I USED AN ANTI SNORING PRODUCT AND IT AFFECTED MY TEETH POSITION. THE PRODUCT WAS BOUGHT FROM THE WEBSITE WWW.ZQUIET.COM. AFTER READING THE 510-K - I FOUND THAT THE PRODUCT HAS TO BE PRESCRIBED BY A DENTIST. NOWHERE ON THE WEBSITE WAS THERE ANY MENTION OF THIS AND I COULD JUST SIMPLY PURCHASE THE PRODUCT ONLINE WITHOUT ANY PRESCRIPTION. DOES THIS NOT VIOLATE THE 510-K - AND FDA RULES? DOSE OR AMOUNT: ONE, FREQUENCY: NIGHTLY. DATES OF USE: (B)(6) 2011. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZQUIET ZQUIET LRK SLEEPING WELL, LLC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other