BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TULA CONTROL UNIT SPARE

    MDR report key: 14029168 · Received April 6, 2022

    Report

    Report Number
    3012130335-2022-00003
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 17, 2022
    Report Date
    June 5, 2023
    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

    INTERNAL COMPLAINT REFERENCE: (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.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION. A VISUAL INSPECTION FOUND A TULAKIT2 ¿ TULA BILATERAL KIT LOT 21120601 WAS RETURNED. NO TYMBION WAS RECEIVED. THE KIT CONTAINED ONE UNOPENED TDS114G. THE OTHER TDS114G WAS NOT RETURNED. THE IONTOPHORESIS CONTROL UNIT, IOCNTRL WAS ALSO RECEIVED. TWO EARSETS WERE RETURNED WITH THE SIZE 3 GREEN EAR PLUGS FROM EP3G LOT 21111201 ATTACHED. THE COIL WAS IN GOOD CONDITION AND NO DAMAGE WAS NOTED. RESIDUE RESEMBLING EARWAX WAS NOTED ON THE EXTERIOR OF THE EAR PLUGS. 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

    H3, H6: THE REPORTED DEVICE WAS NOT RETURNED TO THE DESIGNATED COMPLAINT UNIT FOR INDEPENDENT EVALUATION. A VISUAL INSPECTION FOUND A TULAKIT2 ¿ TULA BILATERAL KIT LOT 21120601 WAS RETURNED. NO TYMBION WAS RECEIVED. THE KIT CONTAINED ONE UNOPENED TDS114G. THE OTHER TDS114G WAS NOT RETURNED. THE IONTOPHORESIS CONTROL UNIT, IOCNTRL WAS ALSO RECEIVED. TWO EARSETS WERE RETURNED WITH THE SIZE 3 GREEN EAR PLUGS FROM EP3G LOT 21111201 ATTACHED. THE COIL WAS IN GOOD CONDITION AND NO DAMAGE WAS NOTED. RESIDUE RESEMBLING EARWAX WAS NOTED ON THE EXTERIOR OF THE EAR PLUGS. 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. A CLINICAL REVIEW STATES THAT THE DEFINITIVE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED; HOWEVER, A USER-RELATED TECHNIQUE MAY HAVE BEEN A CONTRIBUTING FACTOR. ALTHOUGH THE IFU FOR THE TULA DOES CAUTION, ¿THE LEFT AND RIGHT EARS MAY REQUIRE DIFFERENT SIZE EARPLUGS. IF SOLUTION IS SEEN LEAKING FROM AROUND THE EARPLUG, ADEQUATE SEAL HAS NOT BEEN ACHIEVED. IN ADDITION TO, CONFIRMING THE TM IS SUFFICIENTLY NUMB TO PROCEED WITH TUBE PLACEMENT BY OBSERVING THE PATIENT REACTION TO THE TOUCH ON THE TM.¿ . THE IMPACT TO THE PATIENT BEYOND THE REPORTED SIGNIFICANT DISCOMFORT AND THE ABORTED PROCEDURE COULD NOT BE DETERMINED. NO PRODUCT DEFICIENCIES WERE IDENTIFIED AND A ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING BILATERAL TULA TUBE PLACEMENT, THE TYMBION WAS WARMED UTILIZING THE TYMBION WARMER TO DESIRED TEMPERATURE PRIOR THE PATIENT'S ARRIVAL. THE DOCTOR INSPECTED THE PATIENT'S AUDITORY CANALS AND SIZED THE PATIENT TO A EP3G EARPLUG BILATERALLY BEFORE ASSEMBLING THE BILATERAL KIT. THE PATIENT'S EAR CANALS WERE FILLED WITH TYMBION. IN THE FIRST STAGE OF IONTOPHORESIS THE PATIENT EXPERIENCED SIGNIFICANT DISCOMFORT AND THE DOCTOR SET THE CONTROL UNIT TO REDUCE MODE. THE PATIENT BECAME NON-COMPLIANT AND THE DOCTOR PAUSED THE THERAPY. AFTER A SHORT BREAK TYMBION IONTOPHORESIS WAS RESUMED ON THE PATIENT'S LEFT SIDE, WITH THE LEFT AUDITORY CANAL POSITIONED IN A VERTICAL ORIENTATION. SEVERAL LEAKS AND CONTROL UNIT ALERT LIGHTS WERE OBSERVED BEFORE IONTOPHORESIS WAS CONCLUDED SUCCESSFULLY ON THE PATIENT'S LEFT SIDE. THE DOCTOR THEN REPOSITIONED THE PATIENT AND RESUMED IONTOPHORESIS ON THE PATIENT'S RIGHT SIDE WITH THE RIGHT AUDITORY CANAL POSITIONED IN A VERTICAL ORIENTATION. IONTOPHORESIS WAS CONCLUDED SUCCESSFULLY ON THE PATIENT'S RIGHT SIDE. THE DOCTOR OBSERVED THE ANTERIOR-INFERIOR QUADRANT OF THE TYMPANIC MEMBRANE OF THE PATIENT'S RIGHT 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 THAT INDICATED SIGNIFICANT DISCOMFORT AND BEGAN TO CRY. THE DOCTOR THEN OBSERVED THE ANTERIOR-INFERIOR QUADRANT OF THE TYMPANIC MEMBRANE OF THE PATIENT'S LEFT EAR UNDER MAGNIFICATION, AND 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 THAT INDICATED SIGNIFICANT DISCOMFORT AND BEGAN TO CRY. THE DOCTOR REMARKED THAT THE TYMPANIC MEMBRANE APPEARED TO NOT BE ADEQUATELY ANESTHETIZED FOLLOWING THE TYMBION IONTOPHORESIS THERAPY. AN UNSUCCESSFUL ATTEMPT WAS MADE TO PLACE A TULA TUBE ON THE PATIENT'S LEFT SIDE. THE PATIENT IMMEDIATELY DISPLAYED BEHAVIOR THAT INDICATED SIGNIFICANT DISCOMFORT AND BEGAN TO CRY. THE CASE WAS ABORTED AND RESCHEDULED THE PROCEDURE FOR THE OPERATIVE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810251 TULA CONTROL UNIT SPARE TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL 21101901 00840128600139

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male Required Intervention