BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1244043 · Received August 21, 2008

    Report

    Report Number
    2032545-2008-05136
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    June 3, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    k002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INCLUDED IN THE BRAVO PH CAPSULE AND DELIVERY SYS (5-PACK) AND (SINGLE-PACK) FIELD ACTION-FAILURE TO DETACH, PHYSICIAN COMMUNICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PLACING THE BRAVO PH MONITOR, THE CAPSULE WOULD NOT DEPLOY FROM THE DELIVERY SYS. THE CAPSULE FELL INTO THE PT'S STOMACH. NO SERIOUS 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 Q226075

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN