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

Model Number	RE9ITE-DW-HP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the aid was not fixed.Customer stating part of the shell towards top is still broken.The hearing aid works but cutting into patients ear.Could still see skin on the aid as well.Stating the aid was not cleaned.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).A dhr review have been completed.No deviation or changes were found during manufacturing of the device.Investigation is still in progress, a final report will be submitted upon completion.
Additional Manufacturer Narrative
20-sep-2022: manufacturer's ref# sf (b)(4).A dhr review have been completed.No deviation or changes were found during manufacturing of the device.Investigation is still in progress, a final report will be submitted upon completion.20-oct-2022: investigation of the device was not possible, as the device was sent directly to repair and sent back to customer on 29-aug-2022.Final reportability rationale: 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: the case description indicates that the reported issue is related to a poor physical fit, resulting in the left hearing aid "cutting into" the end user's ear.Poor physical fit of hearing aids is identified in the risk analysis and mitigated to an acceptable level through modification of the hearing aid casing or a remake of the hearing aid.The user guide instructs the hearing aid user to contact the hearing care professional if skin irritation occurs.There are no new clinical aspects (e.G.Unforeseen use or clinical conditions) discovered.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 above information in the case still indicates need for reporting.Based on the available information, the malfunction may lead to, or might led to, death or a serious injury if it were to recur or the event / incident did lead to, or might have led to, death or a serious injury.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.
Event or Problem Description
20-sep-2022: it was reported the aid was not fixed.Customer stating part of the shell towards top is still broken.The hearing aid works but cutting into patients ear.Could still see skin on the aid as well.Stating the aid was not cleaned.20-oct-2022: despite multiple requests, no follow up information was received.No further information is expected to receive.This is a 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
• Manufacturer Contact: karen frisk ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 15461454
• Report Number: 3005650109-2022-00036
• Device Sequence Number: 14176163
• Product Code: OSM
• UDI-Device Identifier: 05708296174843
• UDI-Public: 05708296174843
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/20/2022

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: RE9ITE-DW-HP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 08/23/2022
• Initial Report FDA Received Date: 09/21/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2020
• 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: Other
• Patient Sex: Unknown