MAUDE Adverse Event Report: TUSKER MEDICAL INC. TYMBION AND SYRINGE PACK; TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG

Catalog Number	TYMB001
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Codes	Discomfort (2330); Inadequate Pain Relief (2388)
Date of Event	12/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an in-office tula procedure, surgeon faced difficulty to find a size for an atypically small ear; surgeon attempted to use sizes 4, 3, 2 and 1 of earplugs in order to find a proper seal during the fill.Iontophoresis was completed successfully without alarms nor interruptions; however when the surgeon tested the tympanic membrane to determine if it was properly anesthetized utilizing the tds device, the patient complained of discomfort.The procedure was ultimately aborted and the patient rescheduled for the operating room.
Additional Manufacturer Narrative
H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined based on the provided evidence.Lot information was not available therefore a review of the lot history records could not be performed.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.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.

• Brand Name: TYMBION AND SYRINGE PACK
• Common Device Name: TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG
• Manufacturer (Section D): TUSKER MEDICAL INC.; 7000 west william cannon drive; austin TX 78735
• Manufacturer (Section G): TUSKER MEDICAL INC.; 7000 west william cannon drive; austin TX 78735
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 18512422
• Report Number: 3012130335-2024-00002
• Device Sequence Number: 3666559
• Product Code: QJA
• UDI-Device Identifier: 00840128600139
• UDI-Public: 840128600139
• Combination Product (Y/N): Y
• Initial Reporter State: MS
• 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): 05/02/2024

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: TYMB001
• 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: 12/18/2023
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 05/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EP1P.; EP2B.; EP3G.; EP4Y.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Male