BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1123847 · Received August 15, 2008

    Report

    Report Number
    2032545-2008-04999
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Report Date
    July 17, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 FELL OFF IN THE BACK OF THE PATIENT'S MOUTH. 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 Q228118

    Patients

    Seq Age Sex Outcome Treatment
    1