BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TULA TDS 1.14 GROMMET (STR007011)

    MDR report key: 23442205 · Received October 31, 2025

    Report

    Report Number
    3012130335-2025-00006
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    October 8, 2025
    Report Date
    October 31, 2025
    Manufacturer
    TUSKER MEDICAL INC.
    Product Code
    QJA
    UDI-DI
    00885556817742
    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

    H11: INTERNAL COMPLAINT REFERENCE: (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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A TYMPANOSTOMY, ONE (1) TULA TDS DEPLOYED THE TUBE PREMATURELY. THE PROCEDURE WAS CANCELLED AND RESCHEDULED FOR THE OR. NO FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT IS FINE WITH AN OR PLACED TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703269 TULA TDS 1.14 GROMMET (STR007011) TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL INC. UNKNOWN 00885556817742

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O