BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVO CF CAPSULE DELIVERY DEV, 1-PK

    MDR report key: 10507533 · Received September 8, 2020

    Report

    Report Number
    MW5096488
    Event Type
    Injury
    Date Received
    September 8, 2020
    Date of Event
    August 27, 2020
    Report Date
    April 4, 2020
    Manufacturer
    GIVEN IMAGING INC.
    Product Code
    FFT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    DURING UPLOAD BRAVO MONITOR REPORTED 60.3 HOURS OF UNUSABLE DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964832 BRAVO CF CAPSULE DELIVERY DEV, 1-PK ELECTRODE, PH, STOMACH FFT GIVEN IMAGING INC. 48781F

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention