BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 1547106 · Received November 22, 2009

    Report

    Report Number
    9710107-2009-00215
    Event Type
    Malfunction
    Date Received
    November 22, 2009
    Report Date
    November 19, 2009
    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

    Additional Manufacturer Narrative · 1

    NO PT INJURY HAS OCCURRED FOLLOWING THIS INCIDENT.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS REPORTED ON 02/19/2009 AS BRAVO CAPSULE WHICH FAILED TO CALIBRATE. DURING INVESTIGATION IN GIVEN IMAGING LABORATORY PERFORMED ON (B) (6) 2009, IT APPEARED THAT THE ACTUAL ROOT CAUSE WAS BRAVO CAPSULE WHITH FAILURE TO ATTACH.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention