BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TULA KIT - BILATERAL

    MDR report key: 20450911 · Received October 15, 2024

    Report

    Report Number
    3012130335-2024-00010
    Event Type
    Injury
    Date Received
    October 15, 2024
    Report Date
    October 15, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TYMPANOSTOMY, THE PATIENT'S EAR WAS THOROUGHLY CLEANED PRIOR THE IONTOPHORESIS WITH THE TULA KIT. THE IONTOPHORESIS WAS SETUP AND COMPLETED WITHOUT ANY COMPLICATIONS. AS THE DOCTOR MADE CONTACT WITH THE TYMPANIC MEMBRANE THE PATIENT SCREAMED IN PAIN AND WOULD NOT LET THE DOCTOR HAVE A SECOND TRY, THEREFORE, THE PARENTS OPTED TO FINISH THE PROCEDURE IN THE OR. THE PARENT MADE A COMMENT AFTERWARD ASKING IF IT WAS LIDOCAINE THAT WAS USED TO NUMB THE AREA BECAUSE THE PATIENT WAS MOSTLY NON-RESPONSIVE TO LIDOCAINE AND RECENTLY HAD A PROCEDURE WITH LIDOCAINE INJECTIONS AND THE LIDOCAINE INJECTIONS WERE LARGELY INEFFECTIVE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32716 TULA KIT - BILATERAL TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL INC. 23022301 00840128600023

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O