BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1080261 · Received July 22, 2008

    Report

    Report Number
    2032545-2008-02933
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 2, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SENT FOLLOWING AN INTERNAL AUDIT. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PLACING A BRAVO PH MONITOR THE CAPSULE WOULD NOT ATTACH TO THE PATIENT'S ESOPHAGUS. THE CAPSULE LODGED IN THE ARYTENOIDS AND WAS LATER OBSERVED IN THE ANTRUM OF THE STOMACH. IT WAS NOT RETRIEVED. 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 Q225158

    Patients

    Seq Age Sex Outcome Treatment
    1