MAUDE Adverse Event Report: SONOVA AG PHONAK; AUDÉO P70-RT

Model Number	0500797P3
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Tinnitus (2103); Partial Hearing Loss (4472)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported sudden loudness on two separate occasions while wireless streaming.Audiogram shows change to the hearing threasholds and onset of tinnitus.The company is in the process of obtaining further information which will be contained in the follow up report.This is the initial report.
Additional Manufacturer Narrative
Device has not been yet received.Organization has made attempts to contact the initial reporter to get the device for further analysis.
Additional Manufacturer Narrative
Organization has made three attempts to contact the intital reporter to get the device for further analysis.However, device has not been yet received.
Event or Problem Description
The patient reported, sudden loudness on two separate occasions.While wireless streaming.Audiogram shows change to the hearing thresholds and onset of tinnitus.Three follow up attempts were made to contact provider.However, no further information on the case could be obtained.The case will be reopened, if any further information becomes available.

• Brand Name: PHONAK
• Common Device Name: AUDÉO P70-RT
• 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: 14218571
• Report Number: 3005085999-2022-00002
• Device Sequence Number: 19867911
• Product Code: OSM
• UDI-Device Identifier: 07613389509809
• UDI-Public: 07613389509809
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 03/09/2022

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: 0500797P3
• Device Catalogue Number: 050-0797-P3
• 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: 03/09/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2021
• 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: Other
• Patient Sex: Male