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

Model Number	RU5ITC-DWC-MP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Estimated date of incident (b)(6) 2024.It was reported hearing aid chipped after being dropped.No harm to user.No further follow up is available.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: 12-sep-2024: manufacturer's investigation is ongoing.A final report will be submitted upon completion of the investigation this is an initial report.
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: 12-sep-2024: manufacturer's investigation is ongoing.A final report will be submitted upon completion of the investigation this is an initial report.27-nov-2024: visual inspection confirm chipped hearing aid.Technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.The clinical investigation concluded: clinical conclusion on the case is that there was no harm to the user.Clinical evaluation according to clin eval plan&rpt,ha&tsg: despite testing against requirements for construction, there is still risk that a hearing aid may be damaged and potentially broken due to unexpected external mechanical force beyond typical use.Should a hearing aid break due to mechanical force, there is a possibility that the damage results in the creation of exposed sharp edges.These sharp edges could potentially cause harm in the ear canal, likely only superficial in nature.If the hearing aid is accidentally dropped to the floor and then cracked or shattered into pieces, it is evaluated as very unlikely that the users may get harmed due to sharp corners and edges as the damage itself is obvious to the users.It is evaluated as highly unlikely that the hearing aid would break in the ear unless force from an external source is present when considering the shell thickness of the hearing aid.Further, the user guide includes a caution not to use a broken hearing aid.Risk register reference: risks involving mechanical damage are generally known, considered in the risk analysis, mitigated and communicated to the user.This risk is deemed to be acceptable.Manufacturer's investigation is final.This is a final report.
Event or Problem Description
Estimated date of incident (b)(6) 2024.It was reported hearing aid chipped after being dropped.No harm to user.No further follow up is available.

• 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: 20210226
• Report Number: 3005650109-2024-00071
• Device Sequence Number: 7800907
• Product Code: OSM
• UDI-Device Identifier: 05708296260409
• UDI-Public: 05708296260409
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/27/2024

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: RU5ITC-DWC-MP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2024
• 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: Female