BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN COVIDIEN RFA PRODUCT

    MDR report key: 3181458 · Received June 14, 2013

    Report

    Report Number
    3004904811-2013-00028
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    February 11, 2013
    Report Date
    May 9, 2013
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE DID NOT RETURN ANY DEVICE OR PROVIDE ANY LOT OR SERIAL NUMBERS THEREFORE NO DEVICE EVALUATION WAS PERFORMED. IF ADDITIONAL INFORMATION IS RECEIVED PERTINENT TO THIS EVENT, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THIS IS AN ADVERSE EVENT RECORDED ON A CRF AS PART OF THE (B)(4) PATIENT REGISTRY. THE PATIENT WAS PROSPECTIVELY ENROLLED WITH 9CM INDEFINITE DYSPLASIA. ONE DAY POST FOCAL ABLATION PROCEDURE, THE PATIENT REPORTED THAT AFTER EATING BREAKFAST, HE VOMITED. THE PATIENT CONTACTED THE TREATING PHYSICIAN'S OFFICE AND WAS INSTRUCTED TO GO TO THE EMERGENCY ROOM (ER). THE PATIENT WAS EVALUATED BY THE ER PHYSICIAN AND ADMITTED TO THE HOSPITAL OVERNIGHT FOR OBSERVATION. AN ESOPHAGRAM WAS PERFORMED WHICH WAS UNREMARKABLE. THE PATIENT WAS DISCHARGED TO HOME THE NEXT DAY WITH NO FURTHER VOMITING OR OTHER CLINICAL SEQUELAE. PER PHYSICIAN THE SEVERITY OF THIS EVENT WAS SERIOUS, THE RELATIONSHIP TO THE DEVICE PROCEDURE WAS UNLIKELY AND THERE WAS NO DEVICE MALFUNCTION. THIS EVENT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270894 UNKNOWN COVIDIEN RFA PRODUCT ELECTROSURGICAL COAGULATION SYSTEM GEI COVIDIEN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization ONDANSETRON, 4MG EVERY 6 HOURS AS NEEDED