BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TULA TDS 1.14 GROMMET

    MDR report key: 17410474 · Received July 27, 2023

    Report

    Report Number
    3012130335-2023-00001
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    July 6, 2023
    Report Date
    September 14, 2023
    Manufacturer
    TUSKER MEDICAL INC.
    Product Code
    QJA
    UDI-DI
    00840128600047
    PMA / PMN Number
    P190016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: CORRECTION IN B5 AND H6 (HEALTH EFFECT - IMPACT CODE).

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4). H10 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. INSUFFICIENT PRODUCT INFORMATION WAS AVAILABLE THEREFORE A MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED. A COMPLAINT HISTORY REVIEW FOUND NO SIMILAR REPORTED EVENTS. THE INSTRUCTIONS FOR USE WAS REVIEWED AND FOUND TO INCLUDE CONDITIONS OF OFF LABEL USE AND TECHNIQUE SPECIFICS, AS WELL AS PRECAUTIONS AND WARNINGS RELATED TO THE USE OF THE DEVICE. 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. A CLINICAL EVALUATION WAS PERFORMED AND CONCLUDED BASED ON THE AVAILABLE INFORMATION NO FURTHER ACTION IS REQUIRED AT THIS TIME. PLEASE REFER TO THE INSTRUCTIONS FOR USE FOR RECOMMENDATIONS ON PROPER USE OF THE DEVICE AND POTENTIAL TROUBLESHOOTING METHODS TO PREVENT FUTURE REOCCURRENCE OF THE REPORTED EVENT. NO CONTAINMENT OR CORRECTIVE ACTIONS ARE RECOMMENDED AT THIS TIME. IF THE PRODUCT ASSOCIATED WITH THIS EVENT IS RETURNED AT A FUTURE DATE, THIS INVESTIGATION WILL BE REOPENED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    H10: INTERNAL COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TYMPANOSTOMY PROCEDURE, THE TULA DELIVERY SYSTEM COULD NOT BE SUCCESSFULLY DEPLOYED. THE FAILURE OCCURRED IN A CLEFT PATIENT THAT HAD VERY SMALL AND UNDEVELOPED ANATOMY. THE EARDRUM WAS ANGLED SO IT WAS NOT POSSIBLE TO GET DIRECT APPOSITION OF THE TDS DEVICE FOR A SUCCESSFUL DEPLOYMENT. AFTER 2 ATTEMPTS ON THE SAME EAR USING A UNILATERAL KIT, THE PROCEDURE WAS ABORTED. A SURGERY IN THE OR WAS SCHEDULED. THE OUTCOME IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TYMPANOSTOMY PROCEDURE, THE TULA DELIVERY SYSTEM COULD NOT BE SUCCESSFULLY DEPLOYED. THE FAILURE OCCURRED IN A CLEFT PATIENT THAT HAD VERY SMALL AND UNDEVELOPED ANATOMY. THE EARDRUM WAS ANGLED SO IT WAS NOT POSSIBLE TO GET DIRECT APPOSITION OF THE TDS DEVICE FOR A SUCCESSFUL DEPLOYMENT. AFTER 2 ATTEMPTS ON THE SAME EAR USING A UNILATERAL KIT, THE PROCEDURE WAS ABORTED. REVISION SURGERY IN THE OR WAS SCHEDULED. THE OUTCOME IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968232 TULA TDS 1.14 GROMMET TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL INC. UNKNOWN 00840128600047

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention