MAUDE Adverse Event Report: RE5ITC-DW-MP, GN RESOUND; HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY

Model Number	RE5ITC-DW-MP,LINX QUATTRO 5,GN RESOUND
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	09/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturers ref#: (b)(4).Summary of investigation findings: the case has been reviewed from a clinical perspective.Clinical evaluation of the event: the description highly indicates that the end user has an allergic reaction to custom hearing aid material.The reaction developed shortly after wearing the molds, as reported.As an allergic reaction takes at least 7 days to develop and typically weeks to months and this reaction developed after a few days, the case details highly indicates that this is an already present condition/developed allergy.Clinical conclusion on the case is that the end-user has an allergic reaction to the hearing aids.The hcp should attempt a different coupling option, such as a different type of hearing aid.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.This case is considered as a single incident and will be included in regular trending.No actions have been initiated based on this individual event.
Event or Problem Description
Description of event according to initial reporter: the patient had an skin allergic reaction to the custom aids they had purchased.There does not appear to be any lasting effects, just a temporary skin reaction.It did not take very long for the reaction to occur - maybe a few hours.When the allergic reaction was also tested on the forearm to see if it was a true allergic reaction, it only took a couple hours for the reaction to show up on the forearm, so the reaction on the ears was most likely around the same time.Patient had reactions in both ears after wearing for a few hours.Medical professional had the allergic reaction tested on another part of the body and also prescribed medication (triamcinolone cream) to resolve symptoms.Medical professional also gave a diagnosis of polychondritis, which the physician feels is also playing a part in the situation.Symptoms: redness, itching, inflammation.

• Brand Name: RE5ITC-DW-MP, GN RESOUND
• Common Device Name: HEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY
• MDR Report Key: 12588020
• Report Number: 3005650109-2021-00012
• Device Sequence Number: 11903475
• Product Code: OSM
• UDI-Device Identifier: 05708296174546
• UDI-Public: 05708296174546
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

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: RE5ITC-DW-MP,LINX QUATTRO 5,GN RESOUND
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 10/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2021
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention