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

Model Number	RE761-DRWC
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Fungal Infection (2419)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient probably sensitive and prone to receive ear infection when ear canal is partly occluded by e.G.Hearing aid.No increased trend seen.Investigation closed without any further action except trending.S/n (b)(4) - right.Mfg date 01/26/2019 - right.
Event or Problem Description
Repeated ear infections that never occurred prior to hearing aids - ent keeps putting on cipro (anti-biotics).Has occurred 3-4 times in the last year - has pus in ear canal that antibiotic clears.Finding moisture inside of aid when checking for sns.Hcp recommends he change domes daily but does not want to open up power dome or use molds since domes easier to change.Patient not wearing hearing aids until infection clears since he wears w/o cleaning - he may be re-introducing the fungus on unclean domes/receivers.

• Brand Name: RESOUND
• Common Device Name: LINX QUATTRO
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 9597123
• Report Number: 3005650109-2020-00004
• Device Sequence Number: 19698222
• Product Code: OSM
• UDI-Device Identifier: 05708296145355
• UDI-Public: 05708296145355
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2020

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: RE761-DRWC
• Device Catalogue Number: 20686202
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/16/2020
• 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: Required Intervention