BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TULA KIT- BILATERAL (NST007069)

    MDR report key: 23272730 · Received October 10, 2025

    Report

    Report Number
    3012130335-2025-00005
    Event Type
    Malfunction
    Date Received
    October 10, 2025
    Date of Event
    September 11, 2025
    Report Date
    December 2, 2025
    Manufacturer
    TUSKER MEDICAL INC.
    Product Code
    QJA
    UDI-DI
    00885556817674
    PMA / PMN Number
    P190016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE (B)(4). H3, H6: THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION FOUND ONE TULA KIT - BILATERAL LOT TUG21251 WAS RETURNED FOR EVALUATION. ALL COMPONENTS WERE RETURNED IN A CLEAR ZIPPER BAGGY INSIDE PRODUCT PACKAGING. THE RED PULL TABS WERE REMOVED FROM BOTH TDS INSERTERS AND THE EARPLUGS AND ELECTRODE PATCHES WERE USED AND CONNECTED TO THE CONTROL UNIT. THE TDS INSERTERS HAD BEEN DEPLOYED, AND NO GROMMETS WERE RETURNED. 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 NO 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. THE ROOT CAUSE COULD NOT BE DETERMINED SINCE THE REPORTED MALFUNCTION COULD NOT BE DUPLICATED DURING THE INVESTIGATION. 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.

    Additional Manufacturer Narrative · 0

    H11: INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A TYMPANOSTOMY, THE IONTOPHORESIS WITH A TULA KIT WAS UNSUCCESSFUL DUE TO THE PATIENT'S TYMPANIC MEMBRANE BEING TOO THICK, AND COULD NOT BE ANESTHETIZED. THE PROCEDURE WAS NOT COMPLETED, AND THE PATIENT DID NOT RECEIVED THE TULA TUBES AT THE MOMENT; HOWEVER, IT WAS RESCHEDULED AND SUCCESSFULLY PERFORMED IN THE OR THE FOLLOWING WEEK. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2487753 TULA KIT- BILATERAL (NST007069) TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG QJA TUSKER MEDICAL INC. TUG21251 00885556817674

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male