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

Model Number	22420174
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's ref: (b)(4).It has been reported that receiver broke a tip(blue tip with dome attached remained in his ear canal).The patient did seek medical help to remove the object from the ear.No further symptoms were reported.Clinical conclusion is that the this has not caused harm to the patient and no medical treatment was prescribed.The clinical investigation concluded that the current clinical evaluation and risk/benefit conclusions herein are sufficient.Technical investigation from the trended case states that there is less glue and this is further impacted by ear wax.Risk assessment: the risk is deemed acceptable.A dhr (l2326264172) review have been completed.No deviation or changes were found during manufacturing of the device.This is a combined initial and final report.Manufacturer's investigation is final.
Event or Problem Description
It has been reported that receiver broke a tip(blue tip with dome attached remained in his ear canal).This happened for the first time.The patient did seek medical help to remove the object from the ear.No further symptoms were reported.No harm caused and no treatment needed.The patient has received new replacement device.

• Brand Name: GN HEARING
• Common Device Name: HEARING AID, AIR-CONDUCTION WITH WIRELESS TECHNOLOGY, PRESCRIPTION
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• Manufacturer Contact: karen frisk ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 16909291
• Report Number: 3005650109-2023-00063
• Device Sequence Number: 6017849
• Product Code: OSM
• UDI-Device Identifier: 05708296254880
• UDI-Public: 05708296254880
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 05/12/2023

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: 22420174
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male