BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO PH MONITORING SYSTEM AND ACCESSORIES

    MDR report key: 2031153 · Received March 17, 2011

    Report

    Report Number
    9710107-2011-00155
    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 ATTACH. THE PATIENT WAS NOT INJURED FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO PH MONITORING SYSTEM AND ACCESSORIES BRAVO PH CAPSULE FFT GIVEN IMAGING LTD. BRAVO PH CAPSULE 14338Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention