MAUDE Adverse Event Report: SONOVA AG PHONAK LYRIC4 (S); HEARING AID, COMPLETELY-IN-CANAL

Model Number	0780062
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Ear infection (4813)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device was fit on (b)(6) 2025 and was in use for 7 days.Device became weak and was removed from the patient's ear.Upon removal excess fluid collection in patient's ear was observed.The fluid was white and somehow thick.The patient went to the urgent care to examine the ear and is receiving antibiotic drops.
Additional Manufacturer Narrative
The investigation is ongoing.The manufacturer has initiated a follow up to receive more information about the incident.A follow up report will be submitted upon availability of new information.
Additional Manufacturer Narrative
The hcp has reported that the situation has been resolved, but did not answer any of the manufacturer's questions regarding the circumstances of the incident and patient condition.The device is not available for the analysis.Due to lack of information it is not possible to determine the exact root cause of this incident.A risk describing skin irritation and infection has been already considered in the accompanying risk file.The manufacturer will observe for trends.This is the final report.

• Brand Name: PHONAK LYRIC4 (S)
• Common Device Name: HEARING AID, COMPLETELY-IN-CANAL
• Manufacturer (Section D): SONOVA AG; laubisruetistrasse 28; stafa, zurich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisruetistrasse 28; stafa, zurich 8712 ; SZ 8712
• MDR Report Key: 21354790
• Report Number: 3005085999-2025-00001
• Device Sequence Number: 8959341
• Product Code: ESD
• UDI-Device Identifier: 07613389250886
• UDI-Public: (01)07613389250886
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 01/15/2025

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: 0780062
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2024
• 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: Other
• Patient Sex: Unknown