BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO

    MDR report key: 2141547 · Received June 13, 2011

    Report

    Report Number
    2141547
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 13, 2011
    Manufacturer
    GIVEN IMAGING
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE BRAVO INSERTION DEVICE WOULD NOT RELEASE THE BRAVO PROBE. THE PROBE WAS ATTACHED TO WALL OF THE ESOPHAGUS AND IT HAD TO BE MANUALLY PULLED OFF THE ESOPHAGUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRAVO BRAVO PH CAPSULE WITH DELIVERY SYSTEM FFT GIVEN IMAGING * 2010-12/14400Q

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR NO OTHER THERAPIES