BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIRAGE QUATTRO FFM SYS MED-AMER

    MDR report key: 1520500 · Received October 30, 2009

    Report

    Report Number
    3004604967-2009-00023
    Event Type
    Other
    Date Received
    October 30, 2009
    Date of Event
    August 30, 2009
    Report Date
    October 30, 2009
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    PMA / PMN Number
    K063122
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2009, THE MASK SYSTEM WAS RECEIVED AT RESMED CORP LOCATED IN (B)(4). A PRELIMINARY INSPECTION WAS PERFORMED WITH NO DEFECTS OBSERVED. THE MASK SYSTEM WAS SENT TO THE DESIGN FACILITY LOCATED IN (B)(4) FOR FURTHER EVALUATION. BASED ON THE CLINICAL OPINION PROVIDED BY RESMED'S MEDICAL DIRECTOR, THE PROBABLE CAUSE IS THAT THE PT DEVELOPED AN ULCERATION DUE TO PRESSURE APPLIED ON THE SKIN FROM THE CPAP MASK. THE ULCERATION THEN BECAME SECONDARILY INFECTED WITH (B)(6) THAT REQUIRED HOSPITALIZATION AND ANTIBIOTICS.

    Description of Event or Problem · 1

    A DME REPORTED A PT USING A RESMED CPAP MASK DEVELOPED AN INFECTION (B)(6) THAT REQUIRED HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGE QUATTRO FFM SYS MED-AMER MIRAGE QUATTRO BZD RESMED LTD 61202

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR