MAUDE Adverse Event Report: SONOVA AG PHONAK AUDÉO M70-R

Model Number	0500485P3
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Hcp has reported that on saturday, (b)(6) 2023, patient's left receiver broke off and remained in the ear canal.The patient had the part removed from the ear at emergency room.Due to receiver being attached to the cerumen in the ear, there was some bleeding following the removal.Patient has been given antibiotic drops for several days.The patient was seen by the hcp monday, (b)(6).Hcp confirmed that the ear looked good and has replaced the broken receiver.Patient has been wearing hearing aids successfully without further issues.This is an initial report.Supplemental reports will be submitted upon availability of further information.
Additional Manufacturer Narrative
Reported receiver is discarded and is not available for analysis.
Additional Manufacturer Narrative
On 21.09.2023 it has been reported that the receiver has been used for 3 years without replacing.This is much longer than the recommended practice.The patient reported that the broken receiver was returned to the provider, however the manufacturer has not received the device for analysis.Supplemental reports will be submitted upon availability of further information.
Additional Manufacturer Narrative
(b)(6) a labelling update has been initiated to indicate the service life of the receiver in the accompanying documentation.This is the final report.

• Brand Name: PHONAK AUDÉO M70-R
• Common Device Name: AUDÉO M70-R
• Manufacturer (Section D): SONOVA AG; incident.reporting@sonova.com; laubisrütistrasse 28; stafa, zurich , che 8712 ; SZ 8712
• Manufacturer Contact: minal maurya ; 750 n commons dr; aurora, IL 60504 ; 6308219589
• MDR Report Key: 17588099
• Report Number: 3005085999-2023-00009
• Device Sequence Number: 6353936
• Product Code: OSM
• UDI-Device Identifier: 07613275640043
• UDI-Public: 07613275640043
• Combination Product (Y/N): N
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/02/2023

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: 0500485P3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2023
• Supplement Date Received by Manufacturer: 08/02/2023; 08/02/2023
• Initial Report FDA Received Date: 08/21/2023
• Supplement Report FDA Received Date: 09/21/2023; 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2020
• 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