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

Model Number	20574204
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's reference: (b)(4).Technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.Pictures of the device set-up was obtained and was reviewed by an audiologist who confirmed that the sportslock was not installed all the way on the receiver.This can then lead to the dome not being fully secured and may lead to the dome falling off.The clinical investigation concluded:it has been reported that the patient had a dome lodged in ear.It looks like the sports lock was incorrectly positioned causing the dome to dislodge in ear.The patient went to er for removal of dome.No further symptoms were reported.Clinical conclusion is that the this has not caused harm to the patient and no medical treatment was prescribed.Clinical evaluation: hearing aids need to have detachable spare parts such as domes.Therefore, eliminating the risk of a spare parts remaining in the ear canal is not possible.The clinical evaluation for the device family does evaluate domes 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.The risk analysis further addresses this hazard.It is known that the risk of an infection is minimal if the dome is removed in a timely manner.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 concluded: the residual risk after the risk control measure(s) is acceptable.No new hazardous situations revealed and no need to update the risk register.This case is being reported since patient required a visit to the er to remove the dome.This is a final report.
Event or Problem Description
On (b)(6) 2023, patient stated dome became lodged in his ear and was stil lodged in his ear when customer service agent called to ask follow-up questions ((b)(6) 2023).Patient did not describe any other symptoms or harm.Patient stated that were waiting to see if dome will work its way out.Patient had fitted in new domes by themselves 3+ weeks earlier.On an unknown date, patient went to er to remove dome from his ear.

• 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: karen frisk ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 17037084
• Report Number: 3005650109-2023-00074
• Device Sequence Number: 15211376
• Product Code: OSM
• UDI-Device Identifier: 05708296088546
• UDI-Public: 05708296088546
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/31/2023

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: 20574204
• 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: 05/02/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2018
• 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