MAUDE Adverse Event Report: SONOVA AG PHONAK VIRTO P90-10 NW O; HEARING AID, ITE (IN-THE-EAR)

Model Number	063000201
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Eczema (4547)
Type of Reportable Event	Serious Injury
Event or Problem Description
When the patient removed his hearing aid from the ear, the faceplate was taken off and a little fragment was stuck in the ear.The patient had to go to a hospital to have the piece removed.The patient had eczema in the tympanic membrane and external auditory canal.The patient was prescribed cetraxal that he needs to apply for 5 days.
Additional Manufacturer Narrative
This is an initial report.Manufacturer has requested for the device to be returned for analysis.Follow up will be submitted upon availability of any additional information.
Additional Manufacturer Narrative
In the follow up, the hcp reported that the patient recovered and that the hearing aid did not malfunction before as well as that it was not exposed to mechanical impact before.The device was not returned for analysis, provided picture was not of sufficiently high quality to support the investigation, while the modeling data for this device are in norm and did not show any abnormalities, therefore it was not possible to determine the exact root cause of this incident.The analysis of similar incidents showed that from (b)(6) 2023 until (b)(6) 2024 there were four simillar, but not reportable complaints worldwide for sonovaite devices.A similar hazardous situation describing ear piece breaking is already considered in the risk file.The accompanying user guide contains information about regular check and maintenance of the hearing aid including the earpieces, as well as, the information for the patient about a possibility of the ear wax detaching and remaining in the ear and the consequent actions that should be taken if this occurs.This is the final report.
Event or Problem Description
When the patient removed his hearing aid from the ear, a piece broke off and a little fragment was stuck in the ear.The patient had to go to a hospital to have the piece removed.The patient had eczema in the tympanic membrane and external auditory canal.The patient was prescribed cetraxal that he needs to be applied for 5 days.

• Brand Name: PHONAK VIRTO P90-10 NW O
• Common Device Name: HEARING AID, ITE (IN-THE-EAR)
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich ·8712 ; SZ ·8712
• Manufacturer Contact: minal maurya ; 750 n commons dr.; aurora, IL 60504 ; 6308219589
• MDR Report Key: 19990011
• Report Number: 3005085999-2024-00019
• Device Sequence Number: 15225681
• Product Code: ESD
• UDI-Device Identifier: 07613389451948
• UDI-Public: (01)07613389451948
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2024

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: Lay User/Patient
• Device Model Number: 063000201
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other
• Patient Age: 51 YR
• Patient Sex: Male