BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVO PH CAPSULE DELIV DEV 1-PK

    MDR report key: 6081588 · Received November 7, 2016

    Report

    Report Number
    9710107-2016-01074
    Event Type
    Injury
    Date Received
    November 7, 2016
    Report Date
    October 17, 2016
    Manufacturer
    GIVEN LTD (ISRAEL)
    Product Code
    FFT
    PMA / PMN Number
    K102543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, A PATIENT HAD AN ESOPHAGEAL ON (B)(6) 2016. THE BRAVO CAPSULE WAS PLACED AND THEN ON (B)(6) 2016, THE PATIENT WENT TO THE ER COMPLAINING OF PAIN. THE PATIENT IS REQUESTING THAT THE CAPSULE BE REMOVED. NO OTHER KNOWN ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733987 BRAVO PH CAPSULE DELIV DEV 1-PK ELECTRODE, PH, STOMACH FFT GIVEN LTD (ISRAEL) FGS-0313 31600Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization