MAUDE Adverse Event Report: SONOVA AG PHONAK AUDÉO P90-R

Model Number	0500771P7
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
The hcp has reported that a patient came into the office with a receiver and a dome stuck in their ear.The hcp tried to remove the part from the patient's ear, but was unsuccessful.The patient went to the emergency room to get the part removed.The removal was successful and the patient was prescribed antibiotic to avoid possible infections.The manufacturer requested the device to be sent back for analysis.Upon further followup, the hcp confirmed that the patient is doing well.The patient does not want to provide additional information.The receiver is not available for the analysis.This is the final report.
Additional Manufacturer Narrative
Upon further followup, the hcp confirmed that the patient is doing well.The patient does not want to provide additional information.The receiver is not available for the analysis.This is the final report.
Event or Problem Description
The hcp has reported that a patient came into the office with a receiver and a dome stuck in their ear.The hcp tried to remove the part from the patient's ear, but was unsuccessful.The patient went to the emergency room to get the part removed.The removal was successful and the patient was prescribed antibiotic to avoid possible infections.The manufacturer requested the device to be sent back for analysis.

• Brand Name: PHONAK AUDÉO P90-R
• Common Device Name: AUDÉO P90-R
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich,ch 8712 ; SZ 8712
• Manufacturer Contact: aleksandra enns-bray ; laubisruetistrasse 28; stafa, zurich, IL 8712 ; SZ 8712 ; 6308219589
• MDR Report Key: 19230080
• Report Number: 3005085999-2024-00009
• Device Sequence Number: 5855284
• Product Code: OSM
• UDI-Device Identifier: 07613389350975
• UDI-Public: (01)07613389350975
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 04/03/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 0500771P7
• 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: 04/03/2024
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2020
• 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