BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1140894 · Received August 28, 2008

    Report

    Report Number
    2032545-2008-05301
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 31, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    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 INFORMATION IS RECEIVED FROM THE HCP. THE DEVICE IS INCLUDED IN THE BRAVO PH CAPSULE AND DELIVERY SYSTEM (5-PACK) AND (SINGLE-PACK) FIELD ACTION - FAILURE TO DETACH, PHYSICIAN COMMUNICATION (IN LATE 2007).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PLACING THE BRAVO PH MONITOR, THE CAPSULE WOULD NOT DEPLOY FROM THE DELIVERY SYSTEM. WHEN THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT, THE CAPSULE FELL OFF. 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 Q232283

    Patients

    Seq Age Sex Outcome Treatment
    1