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

Model Number	0780070
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fluid Discharge (2686); Ear Pain (4812)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient came for a scheduled removal of lyric.The patient didn't report any pain during use and before the removal.Once the device was removed the patient felt pain.The tympanic member was covered by a thick yellow discharge and the majority of the canal was dark red.The hcp referred the patient to ent for treatment.
Additional Manufacturer Narrative
The manufacturer has initiated a follow up to clarify patient outcome and the circumstances of the incident.The risk of accumulation of moisture in the ear due to device's design and sealed fit in the ear has been already considered in the accompanying risk file.The ifu contains information about common side effects such as e.G.Ear pain, moisture and blisters, as well as, information on contraindications and referral criteria.The follow-up reports will be submitted upon availability of new information.
Additional Manufacturer Narrative
The hcp has reported that the ear canal has cleared up and a new lyric was inserted on (b)(6), 10 days after the manufacturer's awareness date.It is unknown what kind of treatment the patient has received, if any.This is the final report.

• Brand Name: PHONAK LYRIC (M)
• 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: 21585181
• Report Number: 3005085999-2025-00004
• Device Sequence Number: 8833263
• Product Code: ESD
• UDI-Device Identifier: 07613389603309
• UDI-Public: (01)07613389603309
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 02/11/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 0780070
• 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: 02/11/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2024
• 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: Female