BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 5106167 · Received September 25, 2015

    Report

    Report Number
    3005172759-2015-00013
    Event Type
    Injury
    Date Received
    September 25, 2015
    Date of Event
    August 28, 2015
    Report Date
    August 28, 2015
    Manufacturer
    ACCLARENT, INC.
    Product Code
    KAM
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT PRODUCTS OF AN UNKNOWN TYPE WERE USED DURING THE PROCEDURE, BUT IT IS NOT KNOWN IF TRADITIONAL SURGICAL INSTRUMENTS MAY HAVE BEEN USED AS WELL. IT IS UNKNOWN IF THE PATIENT HAD A HISTORY OF SEIZURES OR WAS ON ANTI-SEIZURE MEDICATION. IT IS ALSO UNKNOWN WHETHER THE SEIZURE MAY HAVE BEEN CAUSED BY AN ANESTHETIC OR SEDATION GIVEN TO THE PATIENT. NO ACCLARENT DEVICES ARE AVAILABLE TO BE RETURNED FOR EVALUATION AS THEY WERE DISCARDED BY THE USER FACILITY. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS REPORT, A SUPPLEMENTAL REPORT WILL BE FILED. ACCLARENT WILL CONTINUE TO MONITOR THIS PHENOMENON FOR TRENDING PURPOSES.

    Description of Event or Problem · 1

    ACCLARENT WAS INFORMED OF AN EVENT IN WHICH A PATIENT WAS SAID TO HAVE HAD A SEIZURE FOLLOWING A BALLOON SINUPLASTY PROCEDURE PERFORMED IN THE PHYSICIAN'S OFFICE. ACCLARENT PRODUCTS OF AN UNIDENTIFIED TYPE WERE SAID TO HAVE BEEN USED DURING THE PROCEDURE. IT IS NOT KNOWN IF OTHER NON-ACCLARENT DEVICES WERE USED AS WELL. THE PHYSICIAN REPORTED THAT THE BALLOON SINUPLASTY PROCEDURE WENT AS PLANNED WITH NO COMPLICATIONS. AT AN UNKNOWN PERIOD OF TIME FOLLOWING THE COMPLETION OF THE PROCEDURE, THE PATIENT WAS SAID TO HAVE HAD A SEIZURE AND WAS TAKEN TO THE HOSPITAL. IT IS UNKNOWN WHAT TREATMENT, IF ANY, WAS PROVIDED TO THE PATIENT. ACCLARENT HAS ATTEMPTED TO CONTACT THE REPORTING PHYSICIAN TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE EVENT, BUT HAS RECEIVED NO FURTHER DETAILS OF THE OCCURRENCE, OR THE STATUS OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636282 UNKNOWN UNKNOWN KAM ACCLARENT, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O