BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1000526 · Received February 15, 2008

    Report

    Report Number
    2032545-2008-00735
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 15, 2008
    Report Date
    January 16, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE AND/OR WHEN ADD'L INFO IS REC'D FROM THE HCP.

    Description of Event or Problem · 1

    THE HCP REPORTED THAT WHILE PLACING A BRAVO PH MONITOR, THE CAPSULE TROCAR NEEDLE ADVANCED, BUT THE CAPSULE WOULD NOT ATTACH TO THE PT'S ESOPHAGUS, IT FELL OFF IN THE PT'S MOUTH. THE PT IS RESCHEDULED FOR ANOTHER BRAVO IN SIX WEEKS DUE TO A PUNCTURE WOUND WITHIN THE ESOPHAGUS. FURTHER INFO IS BEING REQUESTED FROM THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q210109

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other