BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZQUIET

    MDR report key: 5276951 · Received December 4, 2015

    Report

    Report Number
    3008797926-2015-00001
    Event Type
    Injury
    Date Received
    December 4, 2015
    Date of Event
    April 23, 2015
    Report Date
    November 30, 2015
    Manufacturer
    SLEEPING WELL, LLC
    Product Code
    LRK
    PMA / PMN Number
    K093407
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    USER CONTACTED MANUFACTURER AND STATED THAT SHE HAD PURCHASED THE DEVICE 7 YEARS AGO. THIS WAS 1 YEAR PRIOR TO THE DEVICE EXISTENCE, AND THAT THERE WAS NO PRODUCT LABELING DISCLOSING SORENESS OF THE TEETH OR TOOTH MOVEMENT, BOTH OF WHICH ARE CLEARLY DISCLOSED IN THE PRODUCT INSTRUCTIONS, AND DEVICE PRODUCT LABEL. SHE CLAIMS THAT SHE DISCONTINUED USE SHORTLY THERE AFTER. ON (B)(6) 2015 SHE PROVIDED INFORMATION THAT SHOWED SHE PURCHASED ZQUIET IN (B)(6) 2011. IN (B)(6) 2015 SHE VISITED A DENTIST AND WAS RECOMMENDED TO HAVE 10 TEETH EXTRACTED DUE TO SEVERE BONE LOSS AND TOOTH DECAY. SHE IS CLAIMING THAT THE ZQUIET THAT SHE USED 4 YEARS PRIOR WAS THE CAUSE OF HER REQUIRING THE 10 TEETH TO BE EXTRACTED. LOOSE TEETH AND PERIODONTAL DISEASE ARE LISTED CONTRAINDICATIONS FOR PRODUCT USE AND IT APPEARS THAT SHE HAD A HISTORY OF ADVANCED PERIODONTAL DISEASE AND BONE LOSS. A REQUEST FOR PRIOR MEDICAL AND DENTAL RECORDS HAVE BEEN REQUESTED BUT NOT PROVIDED. A REQUEST FOR THE RETURN OF THE DEVICE FOR EVALUATION WAS MADE, BUT THE PATIENT HAS NOT PROVIDED THE DEVICE FOR EVALUATION.

    Description of Event or Problem · 1

    PATIENT CLAIMS THAT SHE PURCHASED ZQUIET DEVICE 7 YEARS AGO TO TREAT SNORING. DEVICE PERFORMED AS INTENDED, BUT PATIENT DESCRIBES THAT IT CREATED TOOTH SORENESS AND TOOTH MOVEMENT. (BOTH OF THESE CONDITIONS ARE CLEARLY STATED IN THE DEVICE LABELING AND WARNINGS.) SHE DISCONTINUED USE OF THE DEVICE AS RECOMMENDED IN THE PRODUCT LABELING. IN (B)(6) 2015 SHE WENT TO THE DENTIST AND WAS RECOMMENDED THAT SHE HAVE 10 TEETH EXTRACTED. SHE IS CLAIMING THAT THE USE OF THE DEVICE CAUSED THE DAMAGE THAT REQUIRED THE TEETH TO BE EXTRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797003 ZQUIET ZQUIET LRK SLEEPING WELL, LLC ZQR17 AA-1003

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability