BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1140897 · Received August 28, 2008

    Report

    Report Number
    2032545-2008-05291
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PLACING A BRAVO PH MONITOR, THE CAPSULE DID NOT ATTACH TO THE PATIENT'S ESOPHAGUS. AN ENDOSCOPE WAS USED AND THE CAPSULE WAS FOUND IN 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 Q228205

    Patients

    Seq Age Sex Outcome Treatment
    1