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

Model Number	20661405
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's ref#(b)(4).Technical investigation concluded: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.The clinical investigation concluded: case involves a dome lodged in left ear.User went to purchase new aids.The hearing care provider (hcp) did an ear exam and discovered a dome lodged the left ear and suggested user to go to urgent care for removal.The user went to urgent care and they removed the dome.It is reported that the user hasn't been wearing the hearing aid for years and the user thought they were faulty and user is now convinced this is the problem for the increased hearing loss.No infection or other symptom reported.Clinical conclusion is that the lodged dome has not caused harm to the patient and no medical treatment was prescribed.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 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 register conclusion reference: 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 is a final report.
Event or Problem Description
(b)(6) 2023.On saturday ((b)(6) 2023) patient went to costco looking to purchase new aids.When they did an ear exam they discovered a dome lodged in his left ear and suggested he go to urgent care for removal.He immediately went to urgent care and they removed the dome.A physician and technician at patient first (urgent care) removed the dome with instruments.Patient says he hadn't been wearing his aids for some time because he thought they were faulty and is now convinced this is the problem for his increased hearing loss.Device is over a year out of warranty.

• 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 (Section G): GN HEARING A/S; lautrupbjerg 7; ballerup 2750 ; DA 2750
• Manufacturer Contact: karen frisk ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 16760622
• Report Number: 3005650109-2023-00049
• Device Sequence Number: 14186324
• Product Code: OSM
• UDI-Device Identifier: 05708296095087
• UDI-Public: 05708296095087
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/18/2023

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: 20661405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2021
• 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 Age: 67 YR
• Patient Sex: Male