BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TULA EARSET SPARE (NST007064)

    MDR report key: 20938935 · Received December 16, 2024

    Report

    Report Number
    3012130335-2024-00013
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 21, 2024
    Report Date
    January 25, 2025
    Manufacturer
    TUSKER MEDICAL INC.
    Product Code
    QJA
    UDI-DI
    00885556817759
    PMA / PMN Number
    P190016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). H10: A2, A3 AND B5: PATIENT INFORMATION AND EVENT DESCRIPTION UPDATED. H3, H6: A DEVICE DEFICIENCY WAS NOT IDENTIFIED, AND THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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 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. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. IF ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT IS RECEIVED IN THE FUTURE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE: (B)(4). H3, H6: THIS COMPLAINT WAS OPENED BY SMITH+NEPHEW TO DOCUMENT A PRODUCT PROBLEM ASSOCIATED WITH A SMITH+NEPHEW DEVICE. THE REPORTED PROBLEM RELATES 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 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, FOUR (4) EARPLUGS, SIZE 2 , DID NOT STAY IN EAR CANAL. THE RIGHT SIDE STARTED WITH A SIZE 3, BUT UPON FAILURE A SIZE 2 WAS TRIED BUT SINCE IT FAILED A SIZE 3 WAS TRIED AGAIN. THE EARPAD WAS USED PROPERLY AND SEEMED TO BE WORKING UNTIL A LEAK OCCURRED LESS THAN A MINUTE INTO IONTOPHORESIS. AFTER THAT LEAK, IT WAS UNABLE TO MAINTAIN EAR PLUG STABILIZATION AND TRIED BOTH SIZES 2 AND 3 IN THE CANAL. THE CANAL WAS DRIED EACH TIME BEFORE REPLACING THE PLUG AND FILLING. THE CHILD WAS CRYING AND FIDGETING WHICH EVENTUALLY LED TO THE EARPAD FAILING. ALCOHOL WAS USED TO CLEAN THE EAR CANAL PRIOR TO THE FINAL ATTEMPT ON THE RIGHT SIDE. WITHOUT THE EARPAD IN PLACE, THE EARPLUG SIMPLY POPPED OUT. THE LEFT SIDE WAS STARTED WITH A SIZE 3 WHICH STABILIZED LONGER ON THIS SIDE AS IT ONLY HAD 2 ALARMS. AFTER THE FIRST ALARM, IT WAS REPLACED WITH A SIZE 2. THE SIZE 2 WAS TOO SMALL SO QUICKLY IT WENT BACK TO SIZE 3. THE SIZE 3 MAINTAINED STABILIZATION ON THIS SIDE WELL INTO THE 3RD PHASE OF IONTOPHORESIS AND THE CHILD MANUALLY PULLED IT OUT. UPON RECEIVING THE SECOND ALARM IN THE 3RD PHASE, THE SPECIALIST CHOSE NOT TO PROCEED AS THE RIGHT SIDE WAS NOT SEATING. THE PROCEDURE WAS CANCELLED AND RESCHEDULED FOR THE OR AS THE IONTOPHORESIS WAS NOT COMPLETED. CURRENT PATIENT STATUS IS WELL. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TYMPANOSTOMY, FOUR (4) EARPLUGS SIZE 2 & 3 DID NOT STAY IN EAR CANAL. THE RIGHT SIDE STARTED WITH A SIZE 3, BUT UPON FAILURE A SIZE 2 WAS TRIED BUT SINCE IT FAILED A SIZE 3 WAS TRIED AGAIN. THE EARPAD WAS USED PROPERLY AND SEEMED TO BE WORKING UNTIL A LEAK OCCURRED LESS THAN A MINUTE INTO IONTOPHORESIS. AFTER THAT LEAK, IT WAS UNABLE TO MAINTAIN EAR PLUG STABILIZATION AND TRIED BOTH SIZES 2 AND 3 IN THE CANAL. THE CANAL WAS DRIED EACH TIME BEFORE REPLACING THE PLUG AND FILLING. THE CHILD WAS CRYING AND FIDGETING WHICH EVENTUALLY LED TO THE EARPAD FAILING. ALCOHOL WAS USED TO CLEAN THE EAR CANAL PRIOR TO THE FINAL ATTEMPT ON THE RIGHT SIDE. WITHOUT THE EARPAD IN PLACE, THE EARPLUG SIMPLY POPPED OUT. THE LEFT SIDE WAS STARTED WITH A SIZE 3 WHICH STABILIZED LONGER ON THIS SIDE AS IT ONLY HAD 2 ALARMS. AFTER THE FIRST ALARM, IT WAS REPLACED WITH A SIZE 2. THE SIZE 2 WAS TOO SMALL SO QUICKLY IT WENT BACK TO SIZE 3. THE SIZE 3 MAINTAINED STABILIZATION ON THIS SIDE WELL INTO THE 3RD PHASE OF IONTOPHORESIS AND THE CHILD MANUALLY PULLED IT OUT. UPON RECEIVING THE SECOND ALARM IN THE 3RD PHASE, THE SPECIALIST CHOSE NOT TO PROCEED AS THE RIGHT SIDE WAS NOT SEATING. THE PROCEDURE WAS CANCELLED AND RESCHEDULED FOR THE OR AS THE IONTOPHORESIS WAS NOT COMPLETED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2327884 TULA EARSET SPARE (NST007064) TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL INC. UNKNOWN 00885556817759

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Female