BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TULA KIT- BILATERAL (NST007069)

    MDR report key: 20009015 · Received August 20, 2024

    Report

    Report Number
    3012130335-2024-00005
    Event Type
    Injury
    Date Received
    August 20, 2024
    Date of Event
    July 26, 2024
    Report Date
    September 26, 2024
    Manufacturer
    TUSKER MEDICAL INC.
    Product Code
    QJA
    UDI-DI
    00885556817674
    PMA / PMN Number
    P190016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H11: H2: CORRECTED INFORMATION: D1 AND D4 - CATALOG NUMBER AND UNIQUE IDENTIFIER (UDI) #

    Additional Manufacturer Narrative · 0

    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. 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. 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A TYMPANOSTOMY WHILE USING THE TULA KIT, THE SPECIALIST NO LONGER DEEMED THE PATIENT A GOOD CANDIDATE TO USE THE TULA SYSTEM DUE TO PATIENT TEMPERAMENT. THE PROCEDURE WAS CANCELLED AND RESCHEDULED TO SURGERY IN THE OPERATING ROOM. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2373467 TULA KIT- BILATERAL (NST007069) TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL INC. TUG03241 00885556817674

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R