MAUDE Adverse Event Report: SONOVA AG PHONAK VIRTO M50-312; ITE HEARING AID

Model Number	063-0500-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Event or Problem Description
Due to an accident the patient reportedly experienced a forceful impact on the right ear while the device was in use.The device has been damaged and forced into the ear canal.The patient required a surgical intervention to remove the device and reconstruct the ear canal.The patient reportedly healed from the medical intervention and ent has cleared him to have earmold impression taken and resume the use of the device.This is the final report.
Additional Manufacturer Narrative
Device history record details: device history record was reviewed and found no defect or non conformity at the time of manufacturing.Shell thickness was within the manufacturing specifications.

• Brand Name: PHONAK VIRTO M50-312
• Common Device Name: ITE HEARING AID
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stäfa, zurich 8712 ; SZ 8712
• Manufacturer Contact: minal maurya ; 750 n commons dr.; aurora, IL 60504 ; 6308219589
• MDR Report Key: 14218914
• Report Number: 3005085999-2021-00001
• Device Sequence Number: 4213122
• Product Code: OSM
• UDI-Device Identifier: 07613389276626
• UDI-Public: 07613389276626
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment,Replace
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

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: 063-0500-01
• Device Catalogue Number: 063-0500-01
• 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: 08/06/2021
• Initial Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/26/2021
• 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: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male