BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1081954 · Received July 23, 2008

    Report

    Report Number
    2032545-2008-04299
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 23, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 INFORMATION 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 PATIENT'S ESOPHAGUS. WHEN THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT THE CAPSULE FELL OFF INTO THE PATIENT'S ESOPHAGUS. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q214884

    Patients

    Seq Age Sex Outcome Treatment
    1