MAUDE Adverse Event Report: SONOVA AG PHONAK; AUDEO P50-13T

Model Number	0500790P7
Medical Device Problem Codes	Product Quality Problem (1506); Noise, Audible (3273)
Health Effect - Clinical Codes	Acoustic Shock (1693); Hearing Impairment (1881); Epistaxis (4458)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient presented to his audiologist reporting of a high pitched sound and reported that he had felt a "shock" from the hearing aid.The patient had reportedly visited the emergency room for medical assessment following the initial event.The patient presented with bleeding nose and pain to the right side of the face.Audiological testing revealed changes to the audiogram and these symptoms are yet to be resolved.Audiological testing conducted one month after the reported event indicated hearing loss as severe-to-profound loss, when previously it was considered mild-to-moderate.The patient also had decrease in word recognition scores compared to previous results.He reported "continuing pain".Subsequent testing another month and a half later indicated that the patient's audiogram presented as a moderate loss, showing some recovery since the earlier visit.The audiologist reports that the patient's word recognition scores also improved compared to the earlier session.Investigation of this event is still ongoing and will be part of the supplemental report.When further information is available a supplemental report will be scheduled.
Additional Manufacturer Narrative
15.06.2023 manufacturing and service records have been reviewed for the reported device.A service event was recorded against the serial number in september of 2022.Service was requested for the customer reported that the device was not functioning.The service record indicates that the electronics, housing, and receiver were replaced.The device was tested to release criteria and passed.The next service request recorded in october of 2022 was linked to the reported complaint.As a result, the whole device, and the receiver, were replaced.The complained device was scrappedand is not available for analysis.Follow up is ongoing to confirm full patient recovery.

• Brand Name: PHONAK
• Common Device Name: AUDEO P50-13T
• 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: 16383099
• Report Number: 3005085999-2023-00003
• Device Sequence Number: 12141200
• Product Code: OSM
• UDI-Device Identifier: 07613389509717
• UDI-Public: 07613389509717
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 01/24/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 0500790P7
• Device Catalogue Number: 050-0790-P3
• 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: 01/24/2023
• Supplement Date Received by Manufacturer: 01/24/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2021
• 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: 11 YR
• Patient Sex: Male