BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, BRAVO PH MONITORING

    MDR report key: 2141437 · Received June 8, 2011

    Report

    Report Number
    2141437
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 22, 2011
    Manufacturer
    GIVEN IMAGING INC.
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE BRAVO CAPSULE FOR PH MONITORING DID NOT ATTACH/DEPLOY CORRECTLY. A SECOND DEVICE ATTACHED AND DELPLOYED WITHOUT DIFFICULTY. THE AREA WAS ASSESSED AND NO BLEEDING WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, BRAVO PH MONITORING CATHETER BASED CAPSULE APPLICATOR FFT GIVEN IMAGING INC. UNK 14491Q

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR