BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TULA TDS 1.14 GROMMET

    MDR report key: 12456624 · Received September 10, 2021

    Report

    Report Number
    3012130335-2021-00001
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    August 13, 2021
    Report Date
    February 17, 2022
    Manufacturer
    TUSKER MEDICAL
    Product Code
    QJA
    UDI-DI
    00840128600047
    PMA / PMN Number
    P190016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3, H6: PART OF THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED FOR ANY DAMAGES OR ANOMALIES AND NONE WERE FOUND. THE FINAL TUBE SET POSITION WAS INSPECTED AND IT WAS CONFIRMED THAT THE PLUNGER WAS VISIBLE BEHIND THE CLEAR TIP. THE PE TUBE WAS NOT AVAILABLE AND WAS NOT PRESENT WITHIN THE DEVICE. A DIMENSIONAL EVALUATION FOUND ALL MEASUREMENTS TO BE WITHIN SPECIFICATION. THERE WAS NO WAY TO DETERMINE IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE PRODUCT EVALUATION PROCESS. 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 CONCLUDED THIS WAS A REPEAT ISSUE. A REVIEW OF RISK MANAGEMENT FILES WAS PERFORMED AND THE FAILURE MODE WAS FOUND TO BE WITHIN THE ANTICIPATED RISK IDENTIFIED IN THE DESIGN HISTORY FILES. A CLINICAL/MEDICAL REVIEW WAS ALSO PERFORMED. RESULTS OF WHICH CONCLUDED THAT BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO A USER VS PROCEDURAL EVENT. IT WAS DOCUMENTED THAT THE PATIENT¿S BEHAVIOR WAS DIFFICULT, AND SHE WAS NOT COOPERATING DURING THE PROCEDURE. THE RETAINED TUBE IS IMPLANTABLE, SO BIOCOMPATIBILITY IS NOT AN ISSUE. THE PATIENT IMPACT BEYOND LOCAL IRRITATION/DISCOMFORT, AND/OR MIGRATION CANNOT BE DETERMINED. NO FURTHER CLINICAL/MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. FACTORS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE PATIENT MOVEMENT OR SURGICAL TECHNIQUE. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H1 CORRECTED. THERE IS NO SERIOUS INJURY, ONLY A PRODUCT MALFUNCTION.

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4). TULA IONTOPHORESIS SYSTEM PROVIDES AN ELECTRICAL DOSE OF 6.36 M A MIN TO DRIVE IONS OF LIDOCAINE AND EPINEPHRINE INTO THE TYMPANIC MEMBRANE IN A ~10-12 MINUTE APPLICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OFFICE-BASED ENT PROCEDURE, A TYMPANOSTOMY TUBE PLACED BY THE TULA TUBE DELIVERY SYSTEM WAS MEDIALIZED INTO THE MIDDLE EAR UPON ACTUATION OF THE DEVICE. THE ENT SURGEON STATED THAT DURING DEPLOYMENT, THE PATIENT WAS MOVING, AND SURGEON HAD POOR VISUALIZATION, AND MAYBE OVERCOMPENSATED WITH PRESSURE ON THE DRUM. THE ENT SURGEON STATED THAT THE EAR CANAL LOOKED SMALLER AND THAT THE CHILD WAS FEISTY BUT NOTHING UNUSUAL WAS NOTICED ABOUT THE TISSUE IN THE TARGET LOCATION, TUBE OR THE DEVICE. A DELAY OF APPROXIMATELY 10 MINUTES WAS REPORTED WHILE THE SURGEON ATTEMPTED TO RETRIEVE THE MEDIALIZED TUBE, WHICH ULTIMATELY WAS NOT SUCCESSFUL. A NON-SMITH & NEPHEW TYMPANOSTOMY TUBE (SILICONE ARMSTRONG GROMMET) WAS PLACED USING TRADITIONAL TECHNIQUES, AND THE TULA TYMPANOSTOMY TUBE WAS LEFT RETAINED IN THE MIDDLE EAR CAVITY. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED. THE PATIENT IS DOING WELL, AND STANDARD POST-SURGICAL FOLLOW-UPS ARE PLANNED. THE SURGEON WILL FOLLOW GUIDELINES THAT SUGGEST TUBE MAY BE LEFT IN THE MIDDLE EAR AND WILL EXPLANT IF CHILD NEEDS ANOTHER TUBE SURGERY IN WHICH CASE AN OR PROCEDURE WILL BE RECOMMENDED UNDER GENERAL ANESTHESIA FOR THE PATIENT BASED ON TEMPERAMENT AND NEED TO REMOVE THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354859 TULA TDS 1.14 GROMMET TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL TDS114G 21031701 00840128600047

    Patients

    Seq Age Sex Outcome Treatment
    1 19 MO Female