BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TULA KIT - BILATERAL

    MDR report key: 20450971 · Received October 15, 2024

    Report

    Report Number
    3012130335-2024-00011
    Event Type
    Injury
    Date Received
    October 15, 2024
    Date of Event
    September 24, 2024
    Report Date
    November 22, 2024
    Manufacturer
    TUSKER MEDICAL INC.
    Product Code
    QJA
    UDI-DI
    00840128600023
    PMA / PMN Number
    P190016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE NUMBER: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION REPORTED THAT INCLUDES REFERENCE TO THE USE OF A SMITH+NEPHEW PRODUCT WITHOUT EVIDENCE ABOUT A SPECIFIC PRODUCT PROBLEM. THE REPORTED COMPLICATION RELATES TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED. SMITH+NEPHEW HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON OUR REVIEW OF ALL CURRENTLY AVAILABLE INFORMATION, WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. HOWEVER, AS THE USE OF OUR PRODUCT CANNOT BE EXCLUDED AS A POTENTIAL CAUSE OR CONTRIBUTORY FACTOR TO THE REPORTED ISSUE, WE ARE CONSERVATIVELY SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Additional Manufacturer Narrative · 0

    H10: H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION REVEALED NO ISSUES. A FUNCTIONAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICE THAT THE CONTROL MODULE IS OPERATING WITHIN EXPECTED LIMITS. INTERNAL DATA FOUND THAT THE DEVICE FUNCTIONED AS EXPECTED DURING USE. A REVIEW OF DEVICE RECORDS SHOWED THERE WERE NO INDICATIONS TO SUGGEST THAT THE PRODUCT DID NOT MEET MANUFACTURING SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A COMPLAINT HISTORY REVIEW FOUND SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WERE 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 AND/OR HARM WAS DOCUMENTED APPROPRIATELY, AND THERE WERE NO INDICATIONS TO SUGGEST THE ANTICIPATED RISK IS NOT ADEQUATE. THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE INVESTIGATION. FACTORS THAT CAN CONTRIBUTE TO THE REPORTED EVENT INCLUDE PATIENTS WITH A HISTORY OF SENSITIVITY OR ALLERGIC REACTION TO LIDOCAINE OR OTHER LOCAL ANESTHETICS. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TYMPANOSTOMY, THE IONTOPHORESIS STARTED WITH THE TULA KIT SIZE 2 EARPLUGS THAT WERE TOO SMALL, THUS, THE EARPLUGS WERE SWAPPED TO SIZE 3. THE IONTOPHORESIS PROCEEDED FOR 3 MINUTES AND THE SPEED WAS REDUCED UPON PATIENT DISTRESS. THE PATIENT CALMED DOWN AFTERWARD AND THE IONTOPHORESIS PROCEEDED UNTIL COMPETITION WITH NO COMPLICATIONS. THE DOCTOR PROCEEDED WITH THE TUBE INSERTION AND UPON MAKING CONTACT WITH THE TYMPANIC MEMBRANE THE PATIENT SCREAMED IN PAIN. THE DOCTOR WAS UNABLE TO TRY TO DEPLOY THE TUBE AND THE PARENTS OPTED TO FINISH THE PROCEDURE IN THE OR. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316584 TULA KIT - BILATERAL TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL INC. 23022301 00840128600023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| H