MAUDE Adverse Event Report: SONOVA AG MOXI V5-R; HEARING AID, RECEIVER IN CANAL

Model Number	0506512P8
Medical Device Problem Codes	Overheating of Device (1437); Temperature Problem (3022)
Health Effect - Clinical Code	Blister (4537)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The follow up was initiated to clarify the impact on patient's health and the investigation is ongoing.Supplementary reports will be submitted upon availability of any additional information.
Event or Problem Description
Device got hot and created a blister behind the patient's ear.
Additional Manufacturer Narrative
No further information was received from the hcp after several contact attempts.The device was not returned for analysis and it was not possible to perform root cause analysis.However, similar risks of device overheating already exist in the risk file.There were no complaints or service history for this device prior to this incident.The manufacturer will observe for trends.This is the final report.

• Brand Name: MOXI V5-R
• 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
• MDR Report Key: 20360104
• Report Number: 3005085999-2024-00020
• Device Sequence Number: 8058998
• Product Code: OSM
• UDI-Device Identifier: 07613389597691
• UDI-Public: (01)07613389597691
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/12/2024

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
• Device Model Number: 0506512P8
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2024
• 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