BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 2031104 · Received March 17, 2011

    Report

    Report Number
    9710107-2011-00164
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Report Date
    March 17, 2011
    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. CAPSULE FELL OFF INTO THE PATIENT STOMACH. THE PATIENT WAS NOT INJURED FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO BRAVO PH CAPSULE FFT GIVEN IMAGING LTD. BRAVO PH CAPSULE 14458Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention