BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1243711 · Received November 25, 2008

    Report

    Report Number
    2032545-2008-07743
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 27, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 ADDITIONAL INFORMATION IS RECEIVED FROM THE HCP.

    Description of Event or Problem · 1

    SEE ALSO MANUFACTURER REPORT 2032545200807742. IT WAS REPORTED THAT WHILE PLACING A BRAVO PH MONITOR THE CAPSULE WOULD NOT ATTACH TO THE PATIENT. UPON REMOVAL FROM THE PATIENT THE CAPSULE WAS FOUND IN THE ESOPHAGUS. THIS WAS THE SECOND CAPSULE ATTEMPTED FOR THIS PATIENT. THE PROCEDURE WAS NOT COMPLETED. NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q241168

    Patients

    Seq Age Sex Outcome Treatment
    1