MAUDE Adverse Event Report: SONOVA AG PHONAK AUDEO L50-R

Model Number	050-0875-P6
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon removal of the receiver assembly from the ear, the receiver stuck in the patient's ear.The hcp was able to successfully remove the piece from the patient's ear.The patient didn't require medical attention, nor prescription medication.The patient is doing well after the removal.Reportedly, the receiver broke at the wire cable connection to the receiver.The manufacturer requested the device to be sent back for analysis.This is an initial report.The supplemental reports will be submitted upon availability of new information.
Event or Problem Description
The broken part was not received to the manufacturer.This is the final report.
Additional Manufacturer Narrative
The broken part was not received to the manufacturer, hence it is not possible to determine the root cause of this event.This is the final report.
Event or Problem Description
It was reported that upon removal of the receiver assembly from the ear, the receiver stuck in the patient's ear.The hcp was able to successfully remove the piece from the patient's ear.The patient didn't require medical attention, nor prescription medication.The patient is doing well after the removal.Reportedly, the receiver broke at the wire cable connection to the receiver.The manufacturer requested the device to be sent back for analysis.This is an initial report.The supplemental reports will be submitted upon availability of new information.

• Brand Name: PHONAK AUDEO L50-R
• Common Device Name: PHONAK AUDEO L50-R
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisruetistrasse 28; stafa, zurich, IL 8712 ; SZ 8712 ; 6308219589
• MDR Report Key: 19468580
• Report Number: 3005085999-2024-00013
• Device Sequence Number: 19724399
• Product Code: OSM
• UDI-Device Identifier: 07613389477702
• UDI-Public: (01)07613389477702
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 05/08/2024

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: Lay User/Patient
• Device Model Number: 050-0875-P6
• 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: 05/08/2024
• Supplement Date Received by Manufacturer: 05/08/2024; 05/02/2025
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 08/09/2024; 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2023
• 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: 76 YR
• Patient Sex: Female