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

Model Number	21655200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Manufacturer's investigation: technical investigation concluded: a dhr review has been completed.No deviation or changes were found during manufacturing of the device.The clinical investigation concluded: it has been reported the user's earmould broke.There are no pictures available, and despite attempts it has not been possible to gather information on how it broke, or where the break was in the earmould.There is no report of harm to the user.A dhr review has been completed and confirmed that no deviation or changes were found during manufacturing of the device.There is also risk that a hearing aid's ear mold may be damaged and potentially broken due to unexpected external mechanical force beyond typical use, and this is of most concern in the context of harder acrylic molds.Should an earmold 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 earmold 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, and to consult with a hearing care professional if the earmold is broken.Risk register reference: this risk of device damage is generally known, considered in the risk analysis and communicated to the user.Such risks are generally deemed to be of an acceptable nature.Manufacturer's investigation is final.This is a combined (initial and final) report.
Event or Problem Description
Estimated date of incident (b)(6) 2024 it was reported that the earmould broke.There is no report of any harm to the user.No further information is available, or 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: 19266112
• Report Number: 3005650109-2024-00045
• Device Sequence Number: 12500062
• Product Code: OSM
• UDI-Device Identifier: 05708296213375
• UDI-Public: 05708296213375
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/08/2024

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: 21655200
• 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: 04/08/2024
• Initial Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2023
• 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