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

Model Number	21655000
Medical Device Problem Codes	Product Quality Problem (1506); Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4) manufacturer's investigation is ongoing.A final report will be submitted upon completion of the investigation.This is an initial report.This is a late report (1 day) due to human error.16 jul 2024 the earmould was received by the manufacturer, inspection of the device showed that the brass ring is securely attached to the mould and cannot be removed even with a set of tweesers.Manufacturer investigation concluded that there is no device malfunction.Manufacturers investigation is final.This is a final report.
Event or Problem Description
Estimated date of incident (b)(6) 2024 it was reported that the brass ring that holds the cerustop wax filter fell out of the mould.Nothing ended up in the patient's ear canal.There was no harm to the user following this incident.Further follow up is expected.(b)(6) 2024 investigation of the device showed no defects.The earmould was received by the manufacturer, inspection of the device showed that the brass ring is securely attached to the mould and cannot be removed even with a set of tweesers.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation is ongoing.A final report will be submitted upon completion of the investigation.This is an initial report.This is a late report (1 day) due to human error.
Event or Problem Description
Estimated date of incident (b)(6) 2024.It was reported that the brass ring that holds the cerustop wax filter fell out of the mould.Nothing ended up in the patient's ear canal.There was no harm to the user following this incident.Further follow up is 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: 19547195
• Report Number: 3005650109-2024-00056
• Device Sequence Number: 4811694
• Product Code: OSM
• UDI-Device Identifier: 05708296213351
• UDI-Public: 05708296213351
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 07/17/2024

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: 21655000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown