BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1280463 · Received November 18, 2008

    Report

    Report Number
    2032545-2008-07563
    Event Type
    Malfunction
    Date Received
    November 18, 2008
    Date of Event
    September 22, 2008
    Report Date
    October 20, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    k002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INCLUDED INTO THE BRAVO PH CAPSULE AND DELIVERY SYSTEM 9012B1011 (5-PACK) AND 2012B1001 (SINGLE-PACK) FIELD ACTION - FAILURE TO DETACH, PHYSICIAN COMMUNICATION (2007).

    Description of Event or Problem · 1

    SEE ALSO MFR REPORT 203254-2008-07562. IT WAS REPORTED THAT WHILE PLACING A BRAVO PH MONITOR IN A PEDIATRIC PT, THE CAPSULE FAILED TO DEPLOY CORRECTLY. IT WAS THE SECOND CAPSULE ATTEMPTED. NO INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q230455

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR