BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1003429 · Received February 21, 2008

    Report

    Report Number
    2032545-2008-00826
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 3, 2008
    Report Date
    January 21, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    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 AVAILABLE INFO IS RECEIVED FROM THE HCP.

    Description of Event or Problem · 1

    THE HCP REPORTED THAT WHILE PLACING A BRAVO PH MONITOR THE CAPSULE WOULD 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 Q187511

    Patients

    Seq Age Sex Outcome Treatment
    1