BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXIFIT HC407 NASAL MASK

    MDR report key: 2103277 · Received May 25, 2011

    Report

    Report Number
    9611451-2011-00314
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    December 16, 2010
    Report Date
    April 28, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BYG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE CURRENTLY ENDEAVOURING TO OBTAIN FURTHER INFORMATION WITH REGARD TO THIS COMPLAINT. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION AND THERE IS NO SUGGESTION THAT IT WILL BE RETURNED AT A LATER DATE. WE HAVE ALSO BEEN UNABLE TO RECEIVE ANY FURTHER INFORMATION ABOUT THE INCIDENT FROM THE COMPLAINANT. WITHOUT THE RETURN OF THE COMPLAINT DEVICE OR FURTHER INFORMATION WE ARE UNABLE TO DETERMINE WHAT COULD HAVE CAUSED THE COMPLAINANT TO SUSTAIN THE ALLEGED INJURY. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THIS PRODUCT.

    Description of Event or Problem · 1

    FISHER & PAYKEL HEALTHCARE RECEIVED A REPORT THAT A PATIENT ALLEGEDLY RECEIVED A "LACERATION" TO THE NOSE WHILE USING AN (B)(4) NASAL MASK.

    Description of Event or Problem · 1

    FISHER & PAYKEL HEALTHCARE RECEIVED A REPORT THAT A PATIENT ALLEGEDLY RECEIVED A "LACERATION" TO THE NOSE WHILE USING AN HC407FLEXIFIT NASAL MASK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIFIT HC407 NASAL MASK BYG BYG FISHER & PAYKEL HEALTHCARE LTD HC407U 100308

    Patients

    Seq Age Sex Outcome Treatment
    1