BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAVO PH CAPSULE DELIV DEV 1-PK

    MDR report key: 6188995 · Received December 20, 2016

    Report

    Report Number
    9710107-2016-01146
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Report Date
    July 19, 2016
    Manufacturer
    GIVEN LTD (ISRAEL)
    Product Code
    FFT
    PMA / PMN Number
    K102543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THOUGH THE CAPSULE WAS NOT RECEIVED FOR EVALUATION, THE STUDY WAS RECEIVED. BASED ON THE DATA THAT WAS COLLECTED DURING THE PROCEDURE, IT WAS CLEAR THAT THE TOTAL TIME OF STUDY WAS 48 HOURS. THE STUDY STARTED WITH NORMAL PH VALUE, AND THEN THERE WAS A LOW READING BELOW PH 4- THIS IS TYPICAL OF WHEN A PATIENT IS LYING DOWN OR EATING, SO THESE WERE DEEMED ACCEPTABLE VALUES. THERE WAS A PORTION OF THE GRAPH WHERE THE PH VALUE WAS MISSING. THE ROOT CAUSE FOR THE MISSING PH VALUES COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATING THAT THE PRODUCT WAS RELEASED MEETING FINISHED PRODUCT SPECIFICATIONS.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING AN ESOPHAGEAL PROCEDURE, THERE WAS A HIGH LEVEL OF ARTIFACT DURING THE STUDY. THE DOCTOR PERFORMED ANOTHER PROCEDURE ON THIS PATIENT. NO OTHER KNOWN ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842319 BRAVO PH CAPSULE DELIV DEV 1-PK ELECTRODE, PH, STOMACH FFT GIVEN LTD (ISRAEL) FGS-0313 29781Q

    Patients

    Seq Age Sex Outcome Treatment
    1