BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRAVO PH CAPSULE DELIV DEV 1-PK

    MDR report key: 6221809 · Received January 4, 2017

    Report

    Report Number
    9710107-2017-00009
    Event Type
    Injury
    Date Received
    January 4, 2017
    Date of Event
    November 14, 2016
    Report Date
    December 14, 2016
    Manufacturer
    GIVEN LTD (ISRAEL)
    Product Code
    FFT
    PMA / PMN Number
    K102543
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) (THE PATIENT EXPERIENCED UNINTENDED RADIATION EXPOSURE VIA XRAY) A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE BRAVO CAPSULE DETACHED PRIOR TO THE END OF THE PROCEDURE DURING AN ESOPHAGEAL PROCEDURE. THE ACCOUNT IS NOT SURE IF A REPEAT PROCEDURE WILL BE PERFORMED. NO OTHER KNOWN ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED BY THE ACCOUNT STATED THAT THE CAPSULE WAS IN THE STOMACH PER AN X-RAY PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4168 BRAVO PH CAPSULE DELIV DEV 1-PK ELECTRODE, PH, STOMACH FFT GIVEN LTD (ISRAEL) FGS-0313 32112Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Other