MAUDE Adverse Event Report: SONOVA AG PHONAK; VIRTO P50-10 NW O

Model Number	063050801
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
Hearing aid dispenser has reported that a patient has ingested a hearing aid with a zinc-air battery inside.It is unknown if the right or the left hearing aid has been ingested.Follow up is ongoing to confirm the patient outcome and obtain further information about the event.Supplementary report will be filed upon availability of further information.
Additional Manufacturer Narrative
Three documented follow up attempts have been made to obtain further information on the case.No further information could be obtained.The incident is attributed to a use error.There is no indication of deterioration in the device performance.The risk of ingestion is an inherent risk of the device and is evaluated in the device risk file.The case will be re-assessed in case further information becomes available.Similar events will be further monitored for trends.This is the final report.

• Brand Name: PHONAK
• Common Device Name: VIRTO P50-10 NW O
• 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: 17363911
• Report Number: 3005085999-2023-00008
• Device Sequence Number: 6011489
• Product Code: ESD
• UDI-Device Identifier: 07613389452044
• UDI-Public: 07613389452044
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/21/2023

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: 063050801
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 11/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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 Sex: Unknown