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	09/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's reference number: (b)(4).Investigation is still in progress; a final report will be submitted upon completion.This is an initial report.
Event or Problem Description
Estimated date of the event: 11sep2024.It was reported that an ncased earmold broke.No harm to the user was reported.Further follow up is expected.
Additional Manufacturer Narrative
Manufacturer's reference number: (b)(4).Investigation is still in progress; a final report will be submitted upon completion.This is an initial report.06nov2024: technical investigation concluded: a dhr review have been completed.No deviation or changes were found during manufacturing of the device.Clinical assessment: clinical evaluation of the event: it was reported that the shell broke on an encased earmould.No harm to the user has been reported, no medical attention was reported.Despite several attempts at follow up no further information was provided.A dhr review have been completed and confirmed that no deviation or changes were found during manufacturing of the device.Clinical assessment is that the event did not cause harm to the user.Clinical evaluation according to clin eval plan&rpt, other acc.: 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 assessment: risks related to mechanical damage / force are generally known, considered in the risk analysis, mitigated and communicated to the user.This risk is deemed to be acceptable.Trended case conclusion: the shell broken happens sometimes while the end user holding the ha devices and trying to insert them into ears or sometime due to drop on the floor.The broken devices have to be remade.Improvement of shell material needed and shell printing process performed.Manufacturer's investigation is final.This is a final report.
Event or Problem Description
Estimated date of the event: 11sep2024.It was reported that an ncased earmold broke.No harm to the user was reported.Further follow up is expected.06nov2024: no further follow up information received.

• 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: 20425646
• Report Number: 3005650109-2024-00085
• Device Sequence Number: 20937493
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2023
• 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