BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 5112793 · Received September 30, 2015

    Report

    Report Number
    3005172759-2015-00014
    Event Type
    Injury
    Date Received
    September 30, 2015
    Date of Event
    August 20, 2015
    Report Date
    August 31, 2015
    Manufacturer
    ACCLARENT, INC.
    Product Code
    LRC
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT IS UNABLE TO CONFIRM WHETHER THE PRODUCT USED IN THE PROCEDURE WAS MANUFACTURED BY ACCLARENT OR WHAT OTHER TOOLS MAY HAVE BEEN USED, SUCH AS THOSE USED FOR FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS). THERE WAS NO INDICATION OF ANY PRODUCT MALFUNCTION. IT IS ALSO NOT KNOWN WHETHER THE PROCEDURE WAS PERFORMED AT THE SAME FACILITY WHERE THE REPORTING PHYSICIAN WORKS. A DIFFERENT PHYSICIAN AT THIS FACILITY WAS KNOWN TO HAVE PERFORMED AN ADENOID AND BALLOON SINUPLASTY PROCEDURE ON A (B)(6) MALE USING A ACCLARENT PRODUCTS APPROXIMATELY ONE WEEK PRIOR. HOWEVER, IT IS UNKNOWN IF THIS PATIENT WAS THE ONE THAT HAD THE ISSUE WITH "LOOKING UP." THE SUBJECT DEVICE WAS NOT AVAILABLE FOR EVALUATION, AND ITS WHEREABOUTS ARE UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, 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 DIFFICULTY "LOOKING UP" FOLLOWING AN ADENOID AND BALLOON SINUPLASTY PROCEDURE USING UNKNOWN DEVICES. THE REPORTING PHYSICIAN STATED THAT THE PATIENT'S DIFFICULTY IN "LOOKING UP" ALLEGEDLY OCCURRED FOLLOWING A PROCEDURE PERFORMED BY A SECOND UNNAMED PHYSICIAN IN WHICH AN UNIDENTIFIED BRAND AND MODEL OF BALLOON CATHETER HAD BEEN USED. IT WAS REPORTED THAT THE PATIENT'S MOTHER HAD COME TO THE REPORTING PHYSICIAN FOR A CONSULTATION SOMETIME AFTER THE PROCEDURE. 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
    643865 UNKNOWN UNKNOWN LRC ACCLARENT, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other