BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TULA CONTROL UNIT SPARE

    MDR report key: 14029164 · Received April 6, 2022

    Report

    Report Number
    3012130335-2022-00004
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 17, 2022
    Report Date
    June 15, 2022
    Manufacturer
    TUSKER MEDICAL
    Product Code
    QJA
    UDI-DI
    00840128600139
    PMA / PMN Number
    P190016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10, H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION. A VISUAL INSPECTION FOUND TULA BILATERAL KIT WAS RETURNED. NO TYMBION WAS RECEIVED. THE KIT HAD TWO EMPTY CARTONS. TWO EARSETS WERE RETURNED WITH THE SIZE 2 BLUE EAR PLUGS ATTACHED. THERE WAS BROWN RESIDUE INSIDE THE EARSET. THE IONTOPHORESIS CONTROL UNIT, IOCNTRL AND THE RETURN ELECTRODE WERE ALSO RECEIVED. A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED BECAUSE THE REPORTED DEVICE WAS NOT RECEIVED FOR EVALUATION. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATION UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. A RISK MANAGEMENT REVIEW FOUND THAT THE REPORTED FAILURE WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. AN INVESTIGATION PERFORMED BY THE SUPPLIER DID NOT REVEAL ANY ANOMALIES AND ALL TESTS WERE WITHIN SPECIFICATION. THERE WAS NO WAY TO DETERMINE IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT WAS NOT CONFIRMED. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE PATIENT PREPARATION OR FAILURE OF A CONCOMITANT DEVICE. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE CASE (B)(4). TULA IONTOPHORESIS SYSTEM PROVIDES AN ELECTRICAL DOSE OF 6.36MAMIN TO DRIVE IONS OF LIDOCAINE AND EPINEPHRINE INTO THE TYMPANIC MEMBRANE IN A ~10-12 MINUTE APPLICATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A BILATERAL TULA TUBE PLACEMENT, TYMBION WAS WARMED UTILIZING THE TYMBION WARMER TO DESIRED TEMPERATURE PRIOR THE PATIENT'S ARRIVAL. DOCTOR INSPECTED THE PATIENT'S AUDITORY CANALS AND SIZED THE PATIENT TO A EP2B BILATERALLY BEFORE ASSEMBLING THE BILATERAL KIT. THE PATIENT'S AUDITORY CANALS WERE FILLED WITH TYMBION AND NO LEAKS WERE OBSERVED. TYMBION IONTOPHORESIS WAS INITIATED BILATERALLY AND THE PATIENT WAS COOPERATIVE AND AFFABLE THROUGHOUT THE THERAPY. NO DISCOMFORT WAS OBSERVED DURING TYMBION IONTOPHORESIS, WITH THE EXCEPTION OF THE PATIENT ATTEMPTING TO SCRATCH HIS BACK IN THE GENERAL AREA OF THE RETURN ELECTRODE. TYMBION IONTOPHORESIS CONCLUDED SUCCESSFULLY WITHOUT ANY ALERT LIGHTS. WITHIN 15 MINUTES OF THE CONCLUSION OF TYMBION IONTOPHORESIS, DOCTOR REMOVED THE EARSETS, AND AN UNIDENTIFIED BROWN-COLORED LIQUID WAS OBSERVED IN BOTH EARSETS RESERVOIRS. DOCTOR OBSERVED THE ANTERIOR-INFERIOR QUADRANT OF THE TYMPANIC MEMBRANE OF THE PATIENT'S LEFT EAR UNDER MAGNIFICATION, AND THEN ATTEMPTED TO TEST THE TYMPANIC MEMBRANE FOR ADEQUATE ANESTHESIA EMPLOYING A TM-TAP TECHNIQUE WITH THE RETRACTED TIP OF THE TUBE DELIVERY SYSTEM. THE PATIENT IMMEDIATELY DISPLAYED BEHAVIOR INDICATING SIGNIFICANT DISCOMFORT AND BEGAN TO CRY. DOCTOR REMARKED THAT THE CHORDA TYMPANI APPEARED TO NOT BE ADEQUATELY ANESTHETIZED FOLLOWING THE TYMBION IONTOPHORESIS THERAPY. A SIMILAR TM-TAP WAS NOT ATTEMPTED ON THE PATIENT'S RIGHT SIDE. THE CASE WAS ABORTED AND RESCHEDULE FOR THE OPERATIVE ROOM. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065901 TULA CONTROL UNIT SPARE TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL 21101901 00840128600139

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Male Required Intervention