BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1191844 · Received October 1, 2008

    Report

    Report Number
    2032545-2008-06266
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    August 8, 2008
    Report Date
    September 4, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS INCLUDED IN THE BRAVO PH CAPSULE AND DELIVERY SYSTEM (5-PACK) AND (SINGLE-PACK) FIELD ACTION - FAILURE TO DETACH, PHYSICIAN COMMUNICATION (03-DEC-2007).

    Description of Event or Problem · 1

    SEE ALSO MFR REPORT 2032545-2008-06265. IT WAS REPORTED THAT WHILE PLACING A BRAVO PH MONITOR, THE CAPSULE WOULD NOT DEPLOY FROM THE DELIVERY SYSTEM. THE CAPSULE FELL OFF OF THE DELIVERY SYSTEM UPON REMOVAL FROM THE PT. THIS WAS THE SECOND CAPSULE ATTEMPTED FOR THIS PT. THE PROCEDURE COULD NOT BE COMPLETED. NO INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q210697

    Patients

    Seq Age Sex Outcome Treatment
    1