MAUDE Adverse Event Report: TUSKER MEDICAL INC. TULA KIT- BILATERAL (NST007069); TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG

Catalog Number	72290090
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: internal complaint reference: case-(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 submitting this report in accordance with applicable regulations.If additional investigative findings or information becomes available that alters the conclusions of this report, a follow-up report will be submitted as required.
Event or Problem Description
It was reported that during a tympanostomy, the patient's father believed the child was having an allergic reaction during iontophoresis.The child's forehead was red, and the parents were concerned.The physician came in to address the situation, examined the child, asked the parents some family history questions, and ultimately aborted the procedure out of an abundance of caution and rescheduled for the or.No further complications were reported.
Additional Manufacturer Narrative
H11: internal complaint reference: case-(b)(4).H3, h6: the reported device was received for evaluation.A visual inspection found part of one tula kit - bilateral from lot tug04251 was returned for evaluation.The tds inserters were not returned.The pull tab has been removed from the control unit and the electrode patch and earsets show signs of use.No anomalies were observed.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 of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Based on the information provided information we are unable to conclude specific factors known to contribute to the alleged report.Based on this investigation, the need for corrective action is not indicated.
Additional Manufacturer Narrative
H11: internal complaint reference: (b)(4).H3, h6: the reported device was received for evaluation.A visual inspection found part of one tula kit - bilateral from lot tug04251 was returned.The tds inserters were not returned.The pull tab has been removed from the control unit and the electrode patch and earsets show signs of use.No anomalies were observed.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 of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Based on the information provided information we are unable to conclude specific factors known to contribute to the alleged report.Based on this investigation, the need for corrective action is not indicated.

• Brand Name: TULA KIT- BILATERAL (NST007069)
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 22727008
• Report Number: 3012130335-2025-00004
• Device Sequence Number: 15700640
• Product Code: QJA
• UDI-Device Identifier: 00885556817674
• UDI-Public: 885556817674
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/18/2025
• Device Catalogue Number: 72290090
• Device Lot Number: TUG04251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 09/25/2025; 10/13/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/30/2025; 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2025
• 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
• Patient Age: 24 MO
• Patient Sex: Male