MAUDE Adverse Event Report: SONOVA AG PHONAK AUDÉO L90-R

Model Number	0500889P5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for analysis at the time of the report.However, device is requested to be sent back for analysis.
Event or Problem Description
An hcp has reported that a receiver broke off in patient's ear.The receiver has been removed by an ent.Upon follow up, the patient reported pain, blood and discharge from the left ear after removal of the part from the ear canal.The ent has prescribed the patient antibiotic spray for the 10 subsequent days after removal.The patient has currently discontinued the use of the hearing aids.This is the initial report.Supplemental reports will be submitted upon availability of new information.
Additional Manufacturer Narrative
Upon follow up in (b)(6) 2024, the patient has returned to using the hearing aids full time and did not have any subsequent ear health issues.The left receiver has been in use for 11 months before the incident occurred.The receiver has been discarded by the hcp after the incident and has not been returned for analysis to the manufacturer.The risk of parts of the hearing aid remaining in the ear canal is assessed in the risk file of the device and reflected in the instructions for use.Similar events will be further monitored through the post-market surveillance system of the manufacturer.This is the final report.

• Brand Name: PHONAK AUDÉO L90-R
• Common Device Name: PHONAK AUDÉO L90-R
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa,zurich 8712 ; SZ 8712
• Manufacturer Contact: minal maurya ; 750 n commons dr.; aurora, IL
• MDR Report Key: 18623177
• Report Number: 3005085999-2024-00004
• Device Sequence Number: 12639696
• Product Code: OSM
• UDI-Device Identifier: 07613389477832
• UDI-Public: 07613389477832
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/10/2024

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: 0500889P5
• 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: 01/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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