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

Model Number	21303875
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Local Reaction (2035); Ear infection (4813); Dry Skin (4839)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's ref# (b)(4).Technical investigation concluded: a device history record review have been completed.No deviation or changes were found during manufacturing of the device.The clinical investigation concluded: allergic reaction is identified in the risk analysis and mitigated to an acceptable level through device design by compliance with standards for biocompatibility.Still allergic reactions can occur in rare cases.The clinical evaluation does evaluate allergic reactions and the user guide includes a safety notification instructing the hearing aid wearer to contact the hcp in case of skin irritation.There are no new clinical aspects (e.G.Unforeseen use or clinical conditions) discovered from this event.Therefore, it is concluded that the current clinical evaluation and risk/benefit conclusions herein are sufficient.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 considered reportable as the event / incident did lead to, or might led to, death or a serious injury.This is a final report.
Event or Problem Description
After being fit with the resound one 7 rie devices, clinician reported that end user received a severe reaction to the new light grey domes, resulting in inflammation and bleeding within both ear canals.Portion in front of the ear (anterior to tragus and helix) was also reported to have some irritation from the receivers.The reaction began a couple of days after initial fitting, and the end user could not use the device until follow up appointment, which was two weeks after.No known history of allergies or hypersensitivity.The user was in contact with authorized medical practitioner, who reported it to be an allergic reaction of some kind to the devices.Topical cream was prescribed for treatment.Recommendation from health care professional was to fit custom moulds with hypoallergenic coating.Clinician reported that the user's ear has since healed and are now wearing canal lock moulds with no reported allergic reactions.

• 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: 15549673
• Report Number: 3005650109-2022-00045
• Device Sequence Number: 19312527
• Product Code: OSM
• UDI-Device Identifier: 05708296194575
• UDI-Public: 05708296194575
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2022

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: 21303875
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2022
• 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: Other
• Patient Age: 88 YR
• Patient Sex: Male