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

Model Number	22015870
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	08/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigations: technical investigation concluded: device history register review have been completed.No deviation or changes were found during manufacturing of the device.The clinical investigation concluded: case information states that the receiver had to be removed by a doctor, but that no other treatment was performed, and that the end user was not injured.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 located 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 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 the customer did not report any other concerns/problems followed after the removal of the red receiver tip.This case is considered as a single incident and will be included in regular trending.No actions have been initiated based on this individual event.This case is considered as a single incident and will be included in regular trending.No actions have been initiated based on this individual event.This is a final report.No follow up is expected.
Event or Problem Description
It was reported the customer was inserting reciever into right ear and red tip of the receiver broke off or away from the grey housing of the receiver and got logged in the ear.The customer has extremely small ear canals.The customer did have to seek medical help for removal of the red receiver tip.After removal, no other medical treatment of medication was performed/prescribed.No harm was documented by medical doctor.Hcp is going to search for the right solution for the customer with new hearing aids.

• 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: mandy pagan ; 4067 lagniappe way; tallahassee, FL 32317 ; 8502192521
• MDR Report Key: 15436754
• Report Number: 3005650109-2022-00034
• Device Sequence Number: 5836294
• Product Code: OSM
• UDI-Device Identifier: 05708296221929
• UDI-Public: 05708296221929
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 22015870
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female