MAUDE Adverse Event Report: TUSKER MEDICAL INC. TULA TDS 1.14 GROMMET; TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG

Catalog Number	TDS114G
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	11/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a tympanostomy, the tula earplug size 1 has to be replaced because there was a leak.The patient wouldn't sit still, the physician had 2 short shots on the right ear and 1 on the left ear.After the short shot on the left side, the doctor scheduled the patient for the or.There was no patient injuries but the procedure was not successful as it was not possible to hold the patient still long enough to get proper apposition to the tm.The patient current status is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H10: c, suspected products, item 1: updated.C3: 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.
Additional Manufacturer Narrative
H2: correction in d4 (udi no).
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.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 similar reported events.The instructions for use was reviewed and found instructions to ensure the patient's head is stabilized and the clear tip is fully apposed against the tm.A risk management review found that the reported failure was documented appropriately.Clinical evaluation found that, based on the limited information provided, we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.It was determined the device contributed to the reported event.The complaint was confirmed and the root cause was associated with a failure to follow instructions.The instructions for use warns of complications if the patient's head is not stabilized, and the complaint description states that it was not possible get the patient "to hold still long enough to get proper apposition to the tm." 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: TULA TDS 1.14 GROMMET
• 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: 12957378
• Report Number: 3012130335-2021-00002
• Device Sequence Number: 17498777
• Product Code: QJA
• UDI-Device Identifier: 00840128600078
• UDI-Public: 840128600078
• Combination Product (Y/N): Y
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/31/2022

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: TDS114G
• Device Lot Number: 21031701
• 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: 11/17/2021
• Supplement Date Received by Manufacturer: 11/17/2021; 12/24/2021; 04/26/2022
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 12/21/2021; 12/24/2021; 05/31/2022
• 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: Required Intervention
• Patient Sex: Male