BEUDAMED
    FDA Adverse Event Other Summary report: N

    TULA TUBE DELIVERY SYSTEM

    MDR report key: 3068091 · Received April 11, 2013

    Report

    Report Number
    3005172759-2013-00015
    Event Type
    Other
    Date Received
    April 11, 2013
    Date of Event
    September 12, 2012
    Report Date
    March 13, 2013
    Manufacturer
    ACCLARENT, INC.
    Product Code
    ETD
    PMA / PMN Number
    K082188
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCLARENT FOLLOWED UP ON THIS REPORT TO GATHER ADDITIONAL INFO. THE VP OF MEDICAL AFFAIRS CONTACTED THE REPORTING PHYSICIAN. THE PHYSICIAN REPORTED INSERTING THE SUBJECT DEVICE WITH THE ACCLARENT TUBE DELIVERY SYSTEM ON (B)(6) 2012. THE PROCEDURE WAS SAID TO BE UNEVENTFUL, AND TUBE DELIVERY SYSTEM DEPLOYED THE TUBE PROPERLY PER THE PHYSICIAN. THE PT WAS SEEN FOR TWO OR THREE POSTOPERATIVE VISITS OVER AN UNSPECIFIED PERIOD OF TIME AND HAD NORMALIZATION OF AUDIOMETRIC TESTING. DURING THESE VISITS THE TYMPANOSTOMY TUBE WAS OBSERVED IN "NORMAL ACCEPTABLE POSITION." THE PT LATER MOVED TO ANOTHER CITY, AND SEVERAL MONTHS LATER A DIFFERENT OTOLARYNGOLOGIST NOTED THAT THE RIGHT TYMPANOSTOMY TUBE HAD MEDIALIZED BEHIND A HEALED TYMPANIC MEMBRANE. THE PT WAS REPORTEDLY NOT EXPERIENCING ANY PAIN OR INFECTIONS FROM THE AFFECTED EAR; HOWEVER, THE SECOND OTOLARYNGOLOGIST AND THE FAMILY ELECTED TO SURGICALLY REMOVE THE TUBE FROM THE MIDDLE EAR UNDER GENERAL ANESTHESIA. THE PT WAS SAID TO HAVE TOLERATED THE REMOVAL PROCEDURE WELL, AND THE STATUS OF THE PT AT THIS TIME IS UNK. BASED ON THE INFO PROVIDED, IT APPEARS THE TUBE DELIVERY SYSTEM WORKED APPROPRIATELY, AND THE DEPLOYED TYMPANOSTOMY TUBE REMAINED IN THE INTENDED POSITION FOR SEVERAL MONTHS. THE PT'S HEARING ISSUES, FOR WHICH THE TUBE WAS INSERTED, WERE SAID TO HAVE RESOLVED. THE EXACT CAUSE OF THE REPORTED MEDIALIZATION OF THE TYMPANOSTOMY TUBE OCCURRING AFTER INITIAL INSERTION IS UNK, BUT IS A RARE PHENOMENON THAT IS REFERENCED IN LITERATURE. THE RATE OF OCCURRENCE FOR THIS TYPE OF EVENT DOES NOT APPEAR TO BE OCCURRING AT A RATE GREATER THAN EXPECTED FOR THIS TYPE OF DEVICE.

    Description of Event or Problem · 1

    ACCLARENT WAS NOTIFIED ON (B)(6) 2013, OF AN EVENT THAT OCCURRED ON (B)(6) 2012, DURING A F/U VISIT TO AN OTOLARYNGOLOGIST AT A CLINIC. THE OTOLARYNGOLOGIST NOTED THAT THE RIGHT TYMPANOSTOMY TUBE HAD MEDIALIZED BEHIND THE HEALED TYMPANIC MEMBRANE. THE SURGEON REPORTED THAT THE PT WAS ASYMPTOMATIC. THE PT REPORTEDLY HAD NO EAR PAIN AND/OR EAR INFECTIONS. HOWEVER, THE OTOLARYNGOLOGIST AND THE FAMILY ELECTED TO REMOVE THE TUBE FROM THE MIDDLE EAR UNDER GENERAL ANESTHESIA. THIS WAS DONE WITHOUT ANY ADVERSE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157222 TULA TUBE DELIVERY SYSTEM TYMPANOSTOMY TUBE DELIVERY SYSTEM ETD ACCLARENT, INC. NA 111118B

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Other