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

Model Number	0500889P5
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	Malfunction
Event or Problem Description
The patient (74-year-old male) wearing lumity l90-r hearing aids with 2m receiver with a medium vented dome came to the audiology clinician with a portion of the hearing aid receiver stuck inside the ear.The clinician was able to remove the piece from patient's ear.The clinician reported that the receiver was replaced mid.(b)(6) 2024.The follow up was initiated.The device was requested to be sent for analysis.It was reported that the patient does not experience any residual pain or injury post-removal.This is an initial report.The follow up is ongoing.
Additional Manufacturer Narrative
It was reported that the piece came out and remained in the ear while the patient was trying to remove the receiver from the ear.The receiver is received by the manufacturer for the analysis.The initial analysis of the returned receiver shown that there was a lot of debris of the epoxy inside of the device.The epoxy had yellowing discoloration and seemed quite soft, while normally it is clear and transparent and has a high hardness.Such changes to the epoxy are typical when it comes into contact with cerumen.Additionally, the two parts of the broken receiver housing were not fitting well together and a complete closing was only possible by strongly squeezing them together.Risk of receiver remaining in the ear has been already considered in the hearing device risk file analysis.This risk has been also already considered in the manufacturing process chain risk analysis.Risk control measure includes 100% visual inspection, where the gluing gap between the housings get checked.A capa is intitated to investigate this issue.This is the final report.

• Brand Name: PHONAK AUDÉO L90-R
• Common Device Name: AUDÉO L90-R
• Manufacturer (Section D): SONOVA AG; laubisrütistrasse 28; stafa, zurich,ch 8712 ; SZ 8712
• Manufacturer Contact: minal maurya ; .; aurora, IL 60504 ; 6308219589
• MDR Report Key: 19271572
• Report Number: 3005085999-2024-00010
• Device Sequence Number: 20574992
• Product Code: OSM
• UDI-Device Identifier: 07613389477832
• UDI-Public: (01)07613389477832
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 0500889P5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 74 YR
• Patient Sex: Male