BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TULA EARSET SPARE (NST007064)

    MDR report key: 20495029 · Received October 21, 2024

    Report

    Report Number
    3012130335-2024-00012
    Event Type
    Injury
    Date Received
    October 21, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 21, 2024
    Manufacturer
    TUSKER MEDICAL INC.
    Product Code
    QJA
    UDI-DI
    00885556817759
    PMA / PMN Number
    P190016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TYMPANOSTOMY, THE TULA GEN 2 ROTATING ARM WAS DEFECTIVE. THE ROTATING ARM WAS MEANT TO HOLD COUNTER PRESSURE TO HELP HOLD THE EAR PLUG IN PLACE, HOWEVER, THERE WAS SIGNIFICANT PATIENT MOVEMENT AND THE ROTATING ARM CAME LOOSE TOO EASILY AND IT ENDED UP BECOMING AN HINDRANCE. THE PATIENT GOT SWEATY WHEN GOT WORKED UP AND CRIED, THUS, THE ADHESIVE ON THE PIECE THAT ADHERES TO THE NECK OFTEN CAME OFF AND LOOSE ITS STICKINESS TO THE PATIENTS SWEATY SKIN, BECOMING INEFFECTIVE. THE PROCEDURE WAS CANCELLED AND RESCHEDULED FOR THE OPERATING ROOM. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1931935 TULA EARSET SPARE (NST007064) TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL INC. UNKNOWN 00885556817759

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other