BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1062341 · Received June 18, 2008

    Report

    Report Number
    2032545-2008-03334
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    January 1, 2008
    Report Date
    May 20, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE AND/OR WHEN ADD'L INFO 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 (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. IT WAS DIFFICULT TO DEPRESS THE PLUNGER, BUT ONCE IT WAS DOWN IT TURNED EASILY. WHEN THE DELIVERY SYSTEM WAS REMOVED FROM THE PT THE CAPSULE WAS STILL ATTACHED. THE CAPSULE WOULD FALL OFF IF TOUCHED. 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 Q221983

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK