BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1902974 · Received November 7, 2010

    Report

    Report Number
    9710107-2010-00743
    Event Type
    Malfunction
    Date Received
    November 7, 2010
    Date of Event
    October 19, 2010
    Report Date
    November 7, 2010
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    FFT
    PMA / PMN Number
    K002028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED ON A BRAVO PH CAPSULE THAT FAILED TO DETACH FROM DELIVERY SYSTEM. THE PT WAS SUFFERED FROM LITTLE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO BRAVO PH CAPSULE FFT GIVEN IMAGING LTD. BRAVO PH CAPSULE 13716Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BRAVO PH MONITORING SYSTEM