BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1053232 · Received May 28, 2008

    Report

    Report Number
    2032545-2008-02851
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 28, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    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 PT'S ESOPHAGUS. THE CAPSULE FELL OFF INTO THE BACK OF THE PT'S THROAT. 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 Q216581

    Patients

    Seq Age Sex Outcome Treatment
    1