MAUDE Adverse Event Report: TUSKER MEDICAL INC. TULA KIT - BILATERAL; TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG

Catalog Number	TULAKIT2
Medical Device Problem Codes	Premature Activation (1484); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a tympanostomy, the patient's ear was thoroughly cleaned prior the iontophoresis with the tula kit.The iontophoresis was started and completed without complications.As the doctor made contact with ear drum the patient screamed in pain.The doctor attempted to deploy the tube quickly and made a myringotomy but the tube did not penetrate the tympanic membrane.The tube was retrieved.The patient calmed down enough to allow the doctor to try again but as soon as he made contact with the tympanic membrane again the patient screamed and would not allow for tube deployment.Therefore, the parent's opted to finish the procedure in the or.No further complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).H3, h6: this complaint was opened by smith+nephew to document a patient complication related to a product problem with a smith+nephew device.The reported issue(s) relate 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 information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.A visual inspection revealed no issues.A functional evaluation was performed on the returned device that the control module is operating within expected limits.Internal data found that the device functioned as expected during use.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were 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.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Factors that can contribute to the reported event include patients with a history of sensitivity or allergic reaction to lidocaine or other local anesthetics.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: TULA KIT - BILATERAL
• Common Device Name: TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG
• Manufacturer (Section D): TUSKER MEDICAL INC.; 155 jefferson drive; menlo park CA 94025
• Manufacturer (Section G): TUSKER MEDICAL INC.; 155 jefferson drive; menlo park CA 94025
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 20450846
• Report Number: 3012130335-2024-00009
• Device Sequence Number: 7044732
• Product Code: QJA
• UDI-Device Identifier: 00840128600023
• UDI-Public: 840128600023
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P190016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/27/2024
• Device Catalogue Number: TULAKIT2
• Device Lot Number: 23022301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Supplement Date Received by Manufacturer: 11/21/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown