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

Model Number	20419970
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Manufacturers ref: (b)(4).08sep2022: it was reported that the patient injured after sf3 receiver top breaks off and gets lodged in patients ear.The patient reported that the tip and bottom half of the reciever from the patient hearing aid has come off in his ear.From the picture it is clear that the red portion of a sf3 receiver missing from his aid.Sf3 reciever separated when the patient was wearing it causing the tip to go deep in the patient ear canal puncturing the patients ear drum according to the provider, who notified the manufacturer by email.The patient went to er to get it removed and is now seeing ent doctor.The incident caused bleeding and punctured eardrum.27sep2022: follow up information recieved.It was reported that no damage was done to the patients ear.The er got it wrong.The ent was able to remove the broken piece easily and without issue.Nothing more serious than a bit of irritation from the er doctors attempts at removing the tip.This is a combined report (initial and final).No further follow up information is expected.
Additional Manufacturer Narrative
Manufacturers referance # (b)(4).It was reported that no permanent damage the user was caused.The object was removed from the era canal easily and without issues.No perforation of the eardrum confirmed.Technical investigation concluded: device history register 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 the harm reported was superficial with no permanent harm (ie changes in hearing sensitivity) caused.The integrity of the receiver is based on usage and other environmental factors, while it is expected that the receiver be replaced after some extended usage, it is impossible to determine a fixed duration of receiver usage and replacement time.The clinical evaluation for the device family does evaluate detachable spare parts (including receivers and domes) coming loose in the ear canal.This is identified in the risk analysis and mitigated through device design by ensuring a sufficient pull force.The user guide states to contact the hcp if a foreign object or wax is located in the ear canal to reduce the potential risk of harm as far as possible.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 based on the above information the case is still considered reportable as the event / incident might lead to serious injury.This is a combined report (initial and final).No further follow up information is 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: karen frisk ; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 15549363
• Report Number: 3005650109-2022-00043
• Device Sequence Number: 11234142
• Product Code: OSM
• UDI-Device Identifier: 05708296194445
• UDI-Public: 05708296194445
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 10/04/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 20419970
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2021
• 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: Required Intervention
• Patient Sex: Male