MAUDE Adverse Event Report: SONOVA AG PHONAK; VIRTO B90-13

Model Number	063023601
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	03/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023 patient was found in a room with their left ear bleeding and the hearing aid melted and blackened.The device involved is phonak virto b90-13.Patient was taken to the er where they received 3 stitches in their concha.On (b)(6) 2023 patient was seen by the hcp and the ent clinic.Ent removed the stitches and the patient's ear looked well healed.The patient refused to return the device for analysis.Investigation is ongoing.This is the initial report, supplemental report will be issued when more information is available.
Additional Manufacturer Narrative
The device was manufactured in december 2021.No deviations in production process have been identified.The device successfully passed all the quality tests.Issued to customer/user (b)(6) 2021.No further service has been performed on the reported device before the incident.Device has been requested for analysis.But patient has declined to return the device.
Additional Manufacturer Narrative
August 3, 2023 no further information on the incident could be obtained.This is the final report.The manufacturer will reopen the case if further information becomes available.

• Brand Name: PHONAK
• Common Device Name: VIRTO B90-13
• 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: 16868890
• Report Number: 3005085999-2023-00004
• Device Sequence Number: 12127587
• Product Code: OSM
• UDI-Device Identifier: 07613275553169
• UDI-Public: 07613275553169
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/05/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 063023601
• Device Catalogue Number: 063-0236-01
• 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: 04/05/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (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