BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRAGE ACTIVA LT MASK MED-AMER

    MDR report key: 11988494 · Received June 11, 2021

    Report

    Report Number
    3004604967-2021-00693
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    March 5, 2021
    Report Date
    June 11, 2021
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    PMA / PMN Number
    K032916
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MIRAGE ACTIVA USER GUIDE PROVIDES WARNING ON THIS POTENTIAL EFFECT: - ¿USING A MASK MAY CAUSE TOOTH, GUM OR JAW SORENESS OR AGGRAVATE AN EXISTING DENTAL CONDITION. IF SYMPTOMS OCCUR, CONSULT YOUR PHYSICIAN OR DENTIST." RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED, THEREFORE, RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. RESMED REFERENCE#: PR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A PATIENT USING A NASAL MIRAGE ACTIVA MASK ALLEGEDLY STARTED EXPERIENCING ISSUES WITH DENTAL EXTRACTIONS. THE PATIENT CLAIMED THAT HE FELT UNCOMFORTABLE PRESSURE AGAINST HIS UPPER TEETH AND BENEATH THE NOSE EACH DAY IN THE MORNING. ON REPORTEDLY VISITING HIS DENTIST, THE PATIENT ASSERTS THAT HE WAS INFORMED THAT SEVERAL UPPER TEETH WERE LOOSE AND WOULD REQUIRE IMPLANTS. OVER A PERIOD OF THREE YEARS, THE PATIENT REPORTED THAT HE NEEDED TWO DENTAL APPLIANCES, TWO TEMPORARY PARTIAL DENTURES, AND FOUR IMPLANTS AND FOUR BRIDGES IN BETWEEN THE IMPLANTS COVERING EIGHT UPPER TEETH. PER THE PATIENT, THIS OCCURRED ALLEGEDLY BECAUSE THE TEETH WERE LOOSENED BY THE CPAP MASKS. THE PATIENT CLAIMS THAT HE HAS BEEN SEEKING MEDICAL TREATMENT. PATIENT ASSERTS THAT RESMED AS THE MANUFACTURER SHOULD HAVE INFORMED THE PATIENT OF SUCH SIDE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877497 MIRAGE ACTIVA LT MASK MED-AMER BZD RESMED LTD 60148

    Patients

    Seq Age Sex Outcome Treatment
    1