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

Model Number	KE3ITE-DW-MP
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	09/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wax filter was pulled off an in the ear hearing aid.It was the staff at the clinic that pulled it off.Nothing was lost in the ear of the user.Subsequently, no harm resulted from the event.No further follow up is available or expected.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.He clinical investigation concluded: it has been reported that the wax guard is broken on an in the ear device.It was pulled off by the staff.Nothing was lost in the ear of the user, and subsequently there was no harm.Clinical conclusion on the event is that it did not cause any harm.Clinical evaluation according to 0378040 clin eval plan&rpt, ha&tsg and 0378100 clin eval plan&rpt, other acc: hearing aids need to have detachable spare parts as wax filters.Therefore, eliminating the risk of a spare parts remaining in the ear canal is not possible.A wax filter can become detached and remain in the user's ear canal when the hearing aid is removed or if the cerustop bushing has become dislodged from excessive force applied during replacements or cleaning of the wax filter.Without bushing, a replaced cerustop is not secure and may fall out in the ear.The wax filter then constitutes a foreign body in the ear canal and should be removed as soon as possible as it can pose an infection risk.The hazard is identified in the risk analysis and mitigated on device design by ensuring that the wax filter cannot be removed without a tool.The user guide includes an instruction on how to replace a wax filter with a tool and to contact the hcp if a foreign object is located in the ear canal.Risk register 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.Device investigation concluded: received the returned device.The wax buster was found broken, some portion of wax buster missing which including the red clip and white part of wax buster with spring underneath.The red part of filter remains screwed on the sound hole.The wax guard with such condition will not pass the inspection in factory.The original wax buster will be screwed and fasten onto the sound hole.No adjustment on the white part is needed from manufacturing site.The whole wax buster to be removed from shell if require replacement.Based on the potential safety questionnaire investigation, the staff accidentally pull the wax guard off by force.The event not caused harm.The case is related to usability issue.Manufacturer's investigation is final.This is a combined (initial and final) report.

• 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: 20478470
• Report Number: 3005650109-2024-00091
• Device Sequence Number: 15495278
• Product Code: OSM
• UDI-Device Identifier: 05708296207558
• UDI-Public: 05708296207558
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 10/17/2024

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: KE3ITE-DW-MP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2023
• 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
• Patient Age: 83 YR
• Patient Sex: Male