BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FULL FACE MASK

    MDR report key: 1791661 · Received July 29, 2010

    Report

    Report Number
    9611451-2010-00459
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Report Date
    July 1, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    MNT
    PMA / PMN Number
    K060044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MASK IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE MASK AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE BRIDGE OF THE NOSE OF AN RT041 FULL FACE MASK APPEARED "NOT [TO BE] WELL SEATED AND [THE] SEAL APPEARED NOT TO BE GLUED IN". THIS WAS OBSERVED BY THE FACILITY PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FULL FACE MASK MNT FISHER & PAYKEL HEALTHCARE, LTD. RT041L 090714

    Patients

    Seq Age Sex Outcome Treatment
    1