MAUDE Adverse Event Report: SONOVA AG PHONAK AUDEO L-50R; HEARING AID, RECEIVER IN CANAL

Model Number	0500875P1
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022)
Health Effect - Clinical Codes	Burn(s) (1757); Blister (4537)
Type of Reportable Event	Serious Injury
Event or Problem Description
A hcp reported that a patient got blisters behind the ear due to hearing aid getting hot.The patient visited a doctor and was given a cream against burns to treat skin behind the ear.The patient stopped using the device.
Additional Manufacturer Narrative
This is an initial report.Manufacturer has requested for the device to be returned.Follow up will be submitted upon availability of any additional information.
Additional Manufacturer Narrative
The device was returned for analysis to the manufacturer.The device was received for analysis with over discharged battery.It was noted that the chemistry of the battery is faulty, and the battery was unable to retain charge nor to recharge.After exchange of the battery the device performed as normal, showing no temperature excess, exhibiting normal charge, normal discharge: normal operation was observed.It is converged that the battery suffered an internal failure (uncontrolled self-discharge due to a potential short), causing the device to heat up.There were no prior complaints made for the patient's device.In the follow up interview it was established that the patient's ear is healing.Similar risks that could potentially contribute to overheating of the device have already been considered and identified within the risk file.This is the final report.

• Brand Name: PHONAK AUDEO L-50R
• Common Device Name: HEARING AID, RECEIVER IN CANAL
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich 8712 ; SZ 8712
• Manufacturer Contact: minal maurya ; 750 n commons dr.; aurora, IL 60504 ; 6308219589
• MDR Report Key: 19990010
• Report Number: 3005085999-2024-00018
• Device Sequence Number: 7087376
• Product Code: OSM
• UDI-Device Identifier: 07613389477665
• UDI-Public: (01)07613389477665
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 07/25/2024

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: 0500875P1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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