BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT LT FOR HER MASK SYS - USA

    MDR report key: 4291169 · Received November 11, 2014

    Report

    Report Number
    3004604967-2014-00039
    Event Type
    Injury
    Date Received
    November 11, 2014
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K073638
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MASK WAS NOT RETURNED TO RESMED FOR INVESTIGATION. THE PT DISCARDED THE MASK. THE PT IS CURRENTLY BEING TREATED BY AN EYE SPECIALIST. PT IS CURRENTLY ON THERAPY USING A DIFFERENT MASK SYSTEM. THE SAFETY RISK AND OCCURRENCE RATE FOR THIS INCIDENT HAVE BEEN ASSESSED. RESMED'S RISK ANALYSIS CONCLUDES THAT THE RISK IS ACCEPTABLE. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727717 SWIFT LT FOR HER MASK SYS - USA BZD RESMED LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1