MAUDE Adverse Event Report: SONOVA AG PHONAK; AUDÉO L90-R

Model Number	0500889P3
Medical Device Problem Codes	Output Problem (3005); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hearing Impairment (1881); Tinnitus (2103); Vertigo (2134)
Date of Event	04/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The return of the device is anticipated.However device has not yet been received.
Event or Problem Description
Hcp reported that after the hearing aid came back from repair in march 2023, the patient heard static and a loud sound in the left hearing aid.Following the event the patient has experienced a decrease in hearing, vertigo and tinnitus in left ear.The patient saw an ent on (b)(6) 2023 and was prescribed oral steroids.The patient has discontinued the use of the hearing aids and returned them to hcp.This is an initial report.Investigation is ongoing.Supplemental reports will be submitted upon availability of further information.
Additional Manufacturer Narrative
The service order which preceded the incident was entered in march 2023.The device diagnostic codes identify the issues as too weak output response and distorted sound.Moisture (sweat) exposure was noted by diagnosing team, as well as a clogged microphone.The electronics, housing, receiver, and dome were replaced in service.The unit was tested to release criteria on march 13, 2023 and passed.The device has been discarded and will not be available for analysis.
Additional Manufacturer Narrative
August 3, 2023 the hcp has confirmed that the hearing aids were checked at the clinic before they were mailed to the patient.No further information about the current state of the patient could be obtained.This is the final report.The manufacturer will conduct further assessment if new information becomes available.

• Brand Name: PHONAK
• Common Device Name: AUDÉO L90-R
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich che 8712 ; SZ 8712
• Manufacturer Contact: minal maurya ; 750 n commons dr.; aurora, IL 60504 ; 6308219589
• MDR Report Key: 16962200
• Report Number: 3005085999-2023-00007
• Device Sequence Number: 5238292
• Product Code: OSM
• UDI-Device Identifier: 07613389477818
• UDI-Public: 07613389477818
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 04/25/2023

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: Lay User/Patient
• Device Model Number: 0500889P3
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 04/25/2023; 04/25/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 07/06/2023; 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2022
• 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 Sex: Unknown