BEUDAMED
    FDA Adverse Event Other Summary report: N

    SWIFT LT FOR HER MASK SYS - USA

    MDR report key: 1610818 · Received February 6, 2010

    Report

    Report Number
    3004604967-2010-00007
    Event Type
    Other
    Date Received
    February 6, 2010
    Date of Event
    December 28, 2009
    Report Date
    February 5, 2010
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K073638
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MASK WAS NOT RETURNED TO RESMED FOR EVALUATION. RESMED HAS REQUESTED ALL RELEVANT INFORMATION BE PROVIDED SO THAT FURTHER EVALUATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    A CPAP PT CLAIMS THAT THE PRESSURE FROM THEIR MASK BROKE THEIR TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIFT LT FOR HER MASK SYS - USA SWIFT LT FOR HER BZD RESMED LTD. 60588

    Patients

    Seq Age Sex Outcome Treatment
    1