BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1061615 · Received June 17, 2008

    Report

    Report Number
    2032545-2008-03278
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 19, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE, AND/OR WHEN ADDITIONAL INFO IS RECEIVED FROM THE HCP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PLACING THE BRAVO PH MONITOR THE CAPSULE DID NOT ATTACH TO THE PT'S ESOPHAGUS. THE CAPSULE FELL OFF INTO THE PT'S STOMACH. NO SERIOUS INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q217483

    Patients

    Seq Age Sex Outcome Treatment
    1