BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO PH CAPSULE DELIV DEV 1-PK

    MDR report key: 6021288 · Received October 12, 2016

    Report

    Report Number
    9710107-2016-01041
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Report Date
    September 20, 2016
    Manufacturer
    GIVEN LTD (ISRAEL)
    Product Code
    FFT
    PMA / PMN Number
    K102543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE CAPSULE DETACHED BEFORE THE PROCEDURE ENDED, ABOUT HALF HOUR INTO THE PROCEDURE. THE ACCOUNT CONFIRMED THAT A REPEAT PROCEDURE WILL BE NECESSARY DUE TO THE ALLEGED DEVICE MALFUNCTION. NO OTHER ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673690 BRAVO PH CAPSULE DELIV DEV 1-PK ELECTRODE, PH, STOMACH FFT GIVEN LTD (ISRAEL) FGS-0313 30979Q

    Patients

    Seq Age Sex Outcome Treatment
    1