BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRAGE QUATTRO FFM SYS XSML-AMER

    MDR report key: 1730557 · Received June 18, 2010

    Report

    Report Number
    3004604967-2010-00023
    Event Type
    Injury
    Date Received
    June 18, 2010
    Date of Event
    May 17, 2010
    Report Date
    June 18, 2010
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K063122
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 02-JUN-10, THE COMPLAINT PRODUCT 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), (B) (4) FOR A FURTHER EVALUATION. THE DESIGN FACILITY EVALUATED THE MASK SYSTEM AND CONFIRMED THE MASK WAS BUILT TO THE DESIGN SPECIFICATIONS WITH NO ABNORMALITIES OBSERVED. THERE IS INSUFFICIENT INFORMATION AVAILABLE TO DETERMINE THE ROOT CAUSE OF THE PATIENT INJURY. HOWEVER, THE MASK IS UNLIKELY TO HAVE CONTRIBUTED TO THE INJURY IN THE MANNER DESCRIBED DUE TO THE IMPROBABILITY OF CONTACT BETWEEN THE EYE AND THE NOSE BRIDGE AREA OF THE MASK.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A PATIENT WEARING A QUATTRO EXTRA-SMALL MASK OBTAINED AN EYE INJURY AND REQUIRED STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGE QUATTRO FFM SYS XSML-AMER QUATTRO BZD RESMED LTD. 61200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other