BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TULA TDS 1.14 GROMMET

    MDR report key: 20307244 · Received September 26, 2024

    Report

    Report Number
    3012130335-2024-00008
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    September 4, 2024
    Report Date
    September 26, 2024
    Manufacturer
    TUSKER MEDICAL INC.
    Product Code
    QJA
    UDI-DI
    00840128600047
    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

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). 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 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, WHILE TUBE PLACEMENT; THE SURGEON REPORTED A TUBE MEDIALIZATION WITH THE SECOND TDS DEVICE. THE SURGEON REPORTED HE WAS ABLE TO SUCCESSFULLY PLACE A BACK UP DEVICE IN THE TYMPANIC MEMBRANE. THERE WAS A DELAY LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2234653 TULA TDS 1.14 GROMMET TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL INC. UNKNOWN 00840128600047

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown