BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TULA KIT- BILATERAL (NST007069)

    MDR report key: 22727008 · Received August 6, 2025

    Report

    Report Number
    3012130335-2025-00004
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    July 18, 2025
    Report Date
    October 15, 2025
    Manufacturer
    TUSKER MEDICAL INC.
    Product Code
    QJA
    UDI-DI
    00885556817674
    PMA / PMN Number
    P190016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION FOUND PART OF ONE TULA KIT - BILATERAL FROM LOT TUG04251 WAS RETURNED. THE TDS INSERTERS WERE NOT RETURNED. THE PULL TAB HAS BEEN REMOVED FROM THE CONTROL UNIT AND THE ELECTRODE PATCH AND EARSETS SHOW SIGNS OF USE. NO ANOMALIES WERE OBSERVED. 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 NO SIMILAR REPORTED EVENTS. 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 OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE FINDINGS CANNOT LEAD TO A CLEAR CAUSE OF THE REPORTED EVENT. BASED ON THE INFORMATION PROVIDED INFORMATION WE ARE UNABLE TO CONCLUDE SPECIFIC FACTORS KNOWN TO CONTRIBUTE TO THE ALLEGED REPORT. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED.

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE: CASE-(B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PATIENT COMPLICATION RELATED TO A PRODUCT PROBLEM WITH A SMITH+NEPHEW DEVICE. THE REPORTED ISSUE(S) RELATE TO KNOWN INHERENT DEVICE AND/OR 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 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 SUBMITTING THIS REPORT IN ACCORDANCE WITH APPLICABLE REGULATIONS. IF ADDITIONAL INVESTIGATIVE FINDINGS OR INFORMATION BECOMES AVAILABLE THAT ALTERS THE CONCLUSIONS OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED AS REQUIRED.

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE: CASE-(B)(4). H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION FOUND PART OF ONE TULA KIT - BILATERAL FROM LOT TUG04251 WAS RETURNED FOR EVALUATION. THE TDS INSERTERS WERE NOT RETURNED. THE PULL TAB HAS BEEN REMOVED FROM THE CONTROL UNIT AND THE ELECTRODE PATCH AND EARSETS SHOW SIGNS OF USE. NO ANOMALIES WERE OBSERVED. 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 NO SIMILAR REPORTED EVENTS. 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 OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE FINDINGS CANNOT LEAD TO A CLEAR CAUSE OF THE REPORTED EVENT. BASED ON THE INFORMATION PROVIDED INFORMATION WE ARE UNABLE TO CONCLUDE SPECIFIC FACTORS KNOWN TO CONTRIBUTE TO THE ALLEGED REPORT. 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 PATIENT'S FATHER BELIEVED THE CHILD WAS HAVING AN ALLERGIC REACTION DURING IONTOPHORESIS. THE CHILD'S FOREHEAD WAS RED, AND THE PARENTS WERE CONCERNED. THE PHYSICIAN CAME IN TO ADDRESS THE SITUATION, EXAMINED THE CHILD, ASKED THE PARENTS SOME FAMILY HISTORY QUESTIONS, AND ULTIMATELY ABORTED THE PROCEDURE OUT OF AN ABUNDANCE OF CAUTION AND RESCHEDULED FOR THE OR. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568599 TULA KIT- BILATERAL (NST007069) TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL INC. TUG04251 00885556817674

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Male