BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1172888 · Received September 19, 2008

    Report

    Report Number
    2032545-2008-05965
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 20, 2008
    Manufacturer
    ARIZONA DEVICE MANUFACTURING
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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.

    Description of Event or Problem · 1

    IT WAS REPORTEDLY THAT WHILE PLACING THE BRAVO PH MONITOR, THE CAPSULE WOULD NOT DEPLOY FROM THE DELIVERY SYSTEM. THE HANDLE/PLUNGER BROKE DURING THE PROCEDURE. NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO FFT ARIZONA DEVICE MANUFACTURING 9012B1001 Q231546

    Patients

    Seq Age Sex Outcome Treatment
    1