BEUDAMED
    FDA Adverse Event Other Summary report: N

    QUATTRO FX FFM LGE-AMER

    MDR report key: 2614423 · Received June 6, 2012

    Report

    Report Number
    3004604967-2012-00022
    Event Type
    Other
    Date Received
    June 6, 2012
    Date of Event
    May 8, 2012
    Report Date
    June 6, 2012
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    PMA / PMN Number
    K091129
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT MASK WAS RETURNED TO RESMED AND A PRELIMINARY INSPECTION WAS PERFORMED. THERE WERE NO DEFECTS OR ABNORMALITIES OBSERVED. THE MASKS WILL BE SENT TO THE DESIGN HOUSE FOR A FULL ENGINEERING EVALUATION. DENTAL ISSUES ARE A POTENTIAL SIDE EFFECT OF MASK USE AND ARE INCLUDED IN THE "WARNINGS" OF THE QUATTRO FX USER GUIDE: "USING A MASK MAY CAUSE TOOTH, GUM OR JAW SORENESS OR AGGRAVATE AN EXISTING DENTAL CONDITION. IF SYMPTOMS OCCUR, CONSULT YOUR PHYSICIAN OR DENTIST."

    Description of Event or Problem · 1

    A CPAP PT CLAIMS THEIR FULL FACE MASK CAUSED MOVEMENT TO THEIR BOTTOM TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRO FX FFM LGE-AMER BZD BZD RESMED LTD 61702

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability