MAUDE Adverse Event Report: GN HEARING A/S GN RESOUND; HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY

Model Number	21385700
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref (b)(4).22-aug-2024: investigation is still in progress; a final report will be submitted upon completion.
Event or Problem Description
On (b)(6) 2024: it was reported that a piece of receiver stuck in ear.User had to go to the emergency room because a piece of the receiver came loose and got stuck in his ear.It was reported there was no harm to the user.No further follow up expected.
Additional Manufacturer Narrative
Manufacturer's (b)(4).22-aug-2024: investigation is still in progress; a final report will be submitted upon completion 19sep2024: device history record review: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.Clinical evaluation: clinical evaluation of the event: it was reported the user had to go to the emergency room because a piece of the receiver came loose and got stuck in ear.No further symptoms were reported.Clinical conclusion is that the detached receiver has not caused harm to the patient and no medical treatment was prescribed.Clinical evaluation according to clin eval plan&rpt, ha&tsg and clin eval plan&rpt, other acc: the clinical evaluation for the device family does evaluate receivers coming loose in the ear canal.This is identified in the risk analysis and mitigated through device design by ensuring a sufficient pull force (compliance with iec 60601-2-66).The user guide states to contact the hcp if a foreign object or wax is located in the ear canal to reduce the potential risk of harm as far as possible.There are no new clinical aspects (e.G.Unforeseen use or clinical conditions) discovered from this event.Therefore, it is concluded that the current clinical evaluation and risk/benefit conclusions herein are sufficient.Risk assessment: risk related to mechanical damage are generally known mitigated and communicated to the user.For this risk, refer to capa.All resulting actions are contained within the capa which includes assessment of risks and associated updates.Device investigation and trended case investigation concluded: based on the defect picture provided, the glue appear sufficient in the bottom housing.However, investigation on trended case has shown the glue may interact with human earwax and lose the adhesive properties.The manufacturer's investigation is complete.This is a final report.
Event or Problem Description
22-aug-2024: it was reported that a piece of receiver stuck in ear.User had to go to the emergency room because a piece of the receiver came loose and got stuck in his ear.It was reported there was no harm to the user.No further follow up expected.

• Brand Name: GN RESOUND
• Common Device Name: HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• Manufacturer Contact: akanksha roy ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 20046554
• Report Number: 3005650109-2024-00067
• Device Sequence Number: 15464719
• Product Code: OSM
• UDI-Device Identifier: 05708296219452
• UDI-Public: 05708296219452
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 21385700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male