MAUDE Adverse Event Report: GN HEARING A/S RESOUND; LINX2

Model Number	LS961-DRW
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The end user has developed an ear infection shortly after purchasing new hearing aids.Potential sources of infections are if hands are not washed, if the hearing aids are not being proper cleaned and if there have been any scratches to the ear canal.The end user has seen a doctor and has had anti-biotic treatment.The end user is unsure how to clean the hearing aids properly.The left ear is very moist and produces a lot of wax.This makes a liveable environment to a fungus and it is recommended that the end user is routinely checked for earwax by a medical doctor.It has not been possible to obtain additional information about the case, as regarding handling of hearing aids outside the dispenser's office, exchange of domes/wax filters.We have no information regarding previous history of middle ear infection, cleaning process and hygiene and scratches in the ear canal, possibly causing the infection.The user has been fit bilaterally, but the infection only occurred in one ear, why it is unlikely that the type of material being used is the cause of the infection.The end user did not want to return the device as the fungus infection is believed not to root from the device itself, but is related to handling.Especially as the event occurred 2 month after start using the device.The user guide for ls961-drw (400344000 ug,rs linx2 and enya,rie,gb) do direct the end user to a hearing care professional: "consult a hearing care professional if you discover a foreign object in your ear canal, if you experience skin irritation, or if excessive ear wax accumulates with the use of the hearing instrument.".In this case the end user correct contacted a hearing care professional according to instruction.Furthermore the user guide do instruct in how to clean the device.Since the end user has recovered.Further decisions: as the event resulted in an infection that required medical intervention it is reportable to authorities according to our procedures.The event must be reported to: (b)(6), fda as the model is sold in us.Notified body dqs.
Event or Problem Description
Patient has developed an ear infection shortly after purchasing her new hearing aids.

• Brand Name: RESOUND
• Common Device Name: LINX2
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup 2750 ; DA 2750
• MDR Report Key: 7288549
• Report Number: 3005650109-2018-00001
• Device Sequence Number: 1671210
• Product Code: OSM
• UDI-Device Identifier: 05708296074563
• UDI-Public: 05708296074563
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date (Section B): 02/20/2018

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: No Information
• Device Model Number: LS961-DRW
• Device Catalogue Number: 20357810
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Weight: 70