BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO PH CAPSULE DELIEVERY DEV, 1-PK

    MDR report key: 6195342 · Received December 21, 2016

    Report

    Report Number
    9710107-2016-01162
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    November 29, 2016
    Report Date
    December 12, 2016
    Manufacturer
    GIVEN LTD (ISRAEL)
    Product Code
    FFT
    PMA / PMN Number
    K102543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THEY CALLED TO REPORT A SHORT STUDY WITH A BRAVO CAPSULE: LESS THAN 24 HOURS OF A 48 HOUR STUDY. IT IS UNKNOWN IF A REPEAT PROCEDURE WILL BE PERFORMED, AND NO HARM TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844942 BRAVO PH CAPSULE DELIEVERY DEV, 1-PK ELECTRODE, PH, STOMACH FFT GIVEN LTD (ISRAEL) FGS-0313 32112Q

    Patients

    Seq Age Sex Outcome Treatment
    1