BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO PH CAPSULE DELIEVERY DEV, 1- PK

    MDR report key: 6090126 · Received November 9, 2016

    Report

    Report Number
    3005344223-2016-00004
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Report Date
    October 20, 2016
    Manufacturer
    GIVEN IMAGING LTD
    Product Code
    FFT
    PMA / PMN Number
    K102543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN ESOPHAGEAL PROCEDURE, THE RECORDER DID NOT COLLECT ALL OF THE INFORMATION AND THIS RESULTED IN A SHORT STUDY. THERE WAS A RED LED ON THE RECORDER. THE STUDY DURATION WAS 11:33 HOURS. THE ACCOUNT IS UNSURE OF A REPEAT PROCEDURE WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741570 BRAVO PH CAPSULE DELIEVERY DEV, 1- PK ELECTRODE, PH, STOMACH FFT GIVEN IMAGING LTD FGS-0313 31606Q

    Patients

    Seq Age Sex Outcome Treatment
    1