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

Catalog Number	TYMB001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference case- (b)(4).Tula iontophoresis system provides an electrical dose of 6.36mamin to drive ions of lidocaine and epinephrine into the tympanic membrane in a 10-12 minute application.
Event or Problem Description
It was reported that, during tula bmt procedure, the iontophoresis portion of the procedure was successfully completed in nominal mode, however, upon testing the right tympanic membrane (tm) of the child (right ear drum) for adequate anesthetization with tds tip (left side was not tested), it was determined that the tm was not adequately anesthetized to attempt the tube deployment portion of the procedure and aborted the procedure.The procedure was rescheduled for operating room.
Additional Manufacturer Narrative
H3, h6: the reported drug was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Supplier inspection of retained samples did not identify any issues.A review of device records performed by the supplier showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was an isolated event.A supplier evaluation found that, based on the acceptable batch record review, retain samples inspection and final product testing results, there is no reason to believe there is any impact to product quality of the lot.Since no harm has been alleged to this patient and the procedure will be rescheduled for the or, no further clinical/medical assessment is warranted at this time.There was no way to determine if the device contributed to the reported event.The complaint was not confirmed.Factors that could have contributed to the reported event include administration technique, drug storage conditions, patient anatomy, and pathological and psychological factors.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
H10: internal complaint reference case (b)(4).H3, h6: the reported drug was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Supplier inspection of retained samples did not identify any issues.A review of device records performed by the supplier 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.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 supplier evaluation found that, based on the acceptable batch record review, retain samples inspection and final product testing results, there is no reason to believe there is any impact to product quality of the lot.Since no harm has been alleged to this patient and the procedure will be rescheduled for the or, no further clinical/medical assessment is warranted at this time.A device deficiency was not identified and a root cause of the reported event could not be determined.Factors that could have contributed to the reported event include administration technique, drug storage conditions, patient anatomy, and pathological and psychological factors.No containment or corrective actions are recommended at this time.

• Brand Name: TULA KIT - BILATERAL
• Common Device Name: TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG
• Manufacturer (Section D): TUSKER MEDICAL; 155 jefferson drive; suite 200; menlo park CA 94025
• Manufacturer (Section G): TUSKER MEDICAL; 155 jefferson drive; suite 200; menlo park CA 94025
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13290272
• Report Number: 3012130335-2022-00001
• Device Sequence Number: 4599368
• Product Code: QJA
• UDI-Device Identifier: 00840128600139
• UDI-Public: 840128600139
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: TYMB001
• Device Lot Number: 20120202
• 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: 10/06/2021
• Supplement Date Received by Manufacturer: 03/11/2022; 11/02/2023
• Initial Report FDA Received Date: 01/19/2022
• Supplement Report FDA Received Date: 03/17/2022; 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• 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: Required Intervention
• Patient Age: 2 YR
• Patient Sex: Male