MAUDE Adverse Event Report: TUSKER MEDICAL TULA EARPLUG 10-PACK -SIZE 2; TYMPANOSTOMY TUBE DELIVERY PRODUCT WITH DRUG

Catalog Number	EP2B
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during tula procedure, the patient was fitted with size 2 earplug in one ear, the ear was filled appropriately, and the control unit displayed an alert when the hcp attempted to initiate iontophoresis.It was determined that the hcp had attempted to start the channel that was not yet connected; when they pressed the correct channel, iontophoresis initiated appropriately.The surgeon then attempted to place the second earset using a size 2 earplug, determined that it was too small and changed to a size 3 earplug.Then, the ear was filled and iontophoresis initiated.During iontophoresis, the patient was moving significantly; both the parents and multiple hcps attempted to restrain the patient movement.The earsets were dislodged multiple times leading to alerts on the control unit.The alerts may also have been due to leaks.The patient was not able to be distracted with behavior management techniques.The case was aborted.After the patient left, the np stated that they just couldn't get the earsets/earplugs to stay in.Later that evening, the surgeon communicated that he had investigated the earsets after the procedure.He stated his opinion that the earset valve assembly was defective.He attempted to fill the earset using a setup he designed and claims that it does not fill properly with fluid escaping the valve prior to the reservoir being filled.
Additional Manufacturer Narrative
Internal complaint reference: (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.
Additional Manufacturer Narrative
H10: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.This event may require use of a backup device to complete the procedure and may result in a short procedure delay while a backup device is obtained.The event may cause minor or temporary injury requiring no or minor medical intervention.This event did not lead to a death or serious injury, nor would it be likely to cause or contribute to a death or serious injury if it were to recur.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: TULA EARPLUG 10-PACK -SIZE 2
• 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: 15195699
• Report Number: 3012130335-2022-00005
• Device Sequence Number: 5902375
• Product Code: QJA
• UDI-Device Identifier: 00840128600085
• UDI-Public: 840128600085
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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: 03/01/2022
• Device Catalogue Number: EP2B
• Device Lot Number: 21031501
• 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: 05/18/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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 Sex: Unknown