MAUDE Adverse Event Report: GN HEARING A/S RESOUND; PREZA 8

Model Number	PZ861-DRWC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to gn's clinical evaluation document, 0185290, ear infection can in rare occasions emerge from the usage of rie devices, equipped with domes.It can be due to a too tight fit which can lead to a fungal infection.In this case an ent doctor states that the infection "might have been caused by a cross contamination of domes" which indicate that insufficient hygiene/sanitizing procedure during usage could have lead to the infection.Even though there might be other factors contributing to the infection, it cannot be ruled out that the usage of our hearing aids have contributed to this event and lead to an ear infection.The frequency of these types of events are well within the expected range and no corrective actions will be implemented.The case will be closed and trending will continue.S/n (b)(4) - left.Manufacturing date 08/20/2019 - left.
Event or Problem Description
Member came into hearing aid center (hac) with ear infection claiming aids have caused it.Wants complete new set.Dispenser will not refit until medical clearance has been given by ent.Occurred with right hearing aid - ear infection present - went to ent for diagnosis.Ent said it might have been caused by "cross contamination of domes" but hac has strict sanitizing procedure in place - they were demonstrated to the member.Member is now on anti-biotics.

• Brand Name: RESOUND
• Common Device Name: PREZA 8
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, copenhagen 2750 ; DA 2750
• MDR Report Key: 9699812
• Report Number: 3005650109-2020-00006
• Device Sequence Number: 1810780
• Product Code: OSM
• UDI-Device Identifier: 05708296170975
• UDI-Public: 05708296170975
• Combination Product (Y/N): N
• 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): 02/12/2020

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: PZ861-DRWC
• Device Catalogue Number: 20928601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 02/12/2020
• 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