BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1052570 · Received May 22, 2008

    Report

    Report Number
    2032545-2008-02732
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PLACING THE BRAVO PH MONITOR, THE CAPSULE DID NOT ATTACH TO THE PATIENT'S ESOPHAGUS. THE CAPSULE FELL OFF INTO THE PATIENT'S STOMACH. WHEN THE CLINICIAN RETRIEVED THE CAPSULE, BLOOD WAS FOUND IN THE STOMACH, WHICH WAS FROM THE CAPSULE. THE PROCEDURE WAS THEN ABORTED. THE HCP CONFIRMED THAT NO INTERVENTION WAS NEEDED AND THE PATIENT IS OK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK