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

Catalog Number	TULAKIT2
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Emotional Changes (1831)
Date of Event	05/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during a bilateral tympanostomy, while using the tula kit, the patient was having a hard time with iontophoresis, the doctor and the parents tried to calm the patient without success, thus, the procedure was canceled and scheduled for the operating room due to behavioral issues.No further complications were reported.
Additional Manufacturer Narrative
H11: h2: corrected data on: b1 & b2.
Additional Manufacturer Narrative
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 identification information was provided and thus a manufacturing record and a sterilization record review could not be conducted.Based on the information available, 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.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 review states the procedure was canceled and scheduled for the or due to the patient behavior.The impact to the patient was the reported discomfort, the aborted procedure, and the associated risk by adding an operating room procedure.Since no patient harm or other complications were reported, no further clinical/medical assessment can be rendered at this time.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.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• 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: 19499068
• Report Number: 3012130335-2024-00003
• Device Sequence Number: 18135910
• Product Code: QJA
• UDI-Device Identifier: 00840128600023
• UDI-Public: 840128600023
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 08/07/2024

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 Catalogue Number: TULAKIT2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 06/10/2024; 08/06/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 06/10/2024; 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 8 YR
• Patient Sex: Male