BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 939421 · Received April 13, 2007

    Report

    Report Number
    2032545-2007-01334
    Event Type
    Malfunction
    Date Received
    April 13, 2007
    Date of Event
    March 12, 2007
    Report Date
    March 15, 2007
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    k002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    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 INFORMAITION IS RECEIVED FROM THE HCP.

    Description of Event or Problem · 1

    THE HCP REPORTED THAT WHILE PLACING A BRAVO PH MONITOR THE CAPSULE WOULD NOT ATTACH TO THE PATIENT'S ESOPHAGUS. THE CAPSULE FELL OFF IN THE PATIENT'S MOUTH. IT WAS NOTED THAT THE CAPSULE PIN HAD NOT ADVANCED. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT FFT ARIZONA DEVICE MANUFACTURING 9012B1001 179903

    Patients

    Seq Age Sex Outcome Treatment
    1 YR