BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1172894 · Received September 19, 2008

    Report

    Report Number
    2032545-2008-05914
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    July 29, 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
    CO, 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 COMMUNICATIONS.

    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. WHEN THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT THE CAPSULE FELL OFF. 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 Q218317

    Patients

    Seq Age Sex Outcome Treatment
    1