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

Model Number	22420175
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	05/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4) technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.The clinical investigation concluded: it has been reported that 'receiver dome and red part of receiver fell off in member's ear.Member was able to get it out in the office'.No further symptoms were reported.No further follow up received.Clinical conclusion is that the this has not caused harm to the patient and no medical treatment was prescribed.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 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.Manufacturer's investigation is final.This is a final report.
Event or Problem Description
It was reported: receiver dome and red part of receiver fell off in member's ear.Member was able to get it out in the office.No further symptoms were reported.No further follow up received.

• Brand Name: GN HEARING
• 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: 17048998
• Report Number: 3005650109-2023-00072
• Device Sequence Number: 12503948
• Product Code: OSM
• UDI-Device Identifier: 05708296254897
• UDI-Public: 05708296254897
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/01/2023

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: 22420175
• 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: 05/04/2023
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2023
• 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 Sex: Unknown