MAUDE Adverse Event Report: GN HEARING A/S GN RESOUND; PZ861-DRWC,PREZA 8

Model Number	PZ861-DRWC,PREZA 8
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Local Reaction (2035); Skin Irritation (2076)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the clinical evaluation below this case has been decided to be reportable as there has been medical intervention.The user does not have a history of allergy but have nevertheless had a reaction by our device.There is no malfunction.This is considered a single incident and will be included in regular trending.No actions has been initiated based on this individual event.The case has been reviewed from a clinical perspective.Customer reported: end user is experiencing itching and "weeping" when wearing the hearing aids.This started ~8 months after being fitted with the hearing aids.End user has consulted a doctor, who prescribed eardrops due to an infection from scratching the ears.Additionally, the doctor has advised to pause the hearing aids until next doctor-visit, ~a month later.Doctor has advised that the reaction is likely a reaction to latex in the domes.The end user has previously worn resound aids with clear domes for 6+ years without issues.Clinical evaluation of the event: case information states that end user is experiencing a reaction in both ears and that a doctor has been consulted.Doctor has advised that this is most likely a reaction to the material.The domes, provided by gn hearing, are made of silicone material, not latex.There are more than 4000 known chemicals who can act as a contact sensitizing chemicals and the process of contact sensitization lasts typically weeks to months.To identify a potential reaction to the dome silicone material, patch testing can be a solution.Alternative material solution could be impressed hypoallergenic earmoulds.Clinical conclusion on the case is that it is likely that the reaction is a reaction to the hearing aid domes and that this has caused medical intervention (eardrops).Clinical evaluation according to corp proc gen evaluation (b)(4): 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.
Event or Problem Description
Event description as reported by user/patient: pt wore aids since (b)(6) 2020 and everything was fine.About 6-8 weeks ago developed they started itching and "weeping" went to the md and was told that it's likely an allergy to the latex in the domes.Was given eardrops due to an infection from scratching the ears.Has a f/u doctors appointment in about a month and was advised not to wear these aids until that time.Potential safety case.Got aids in (b)(6) 2020 and this started about 6-8 weeks ago.Wore prior resound aids with the clear domes for 6+ years with no issues.Comment by local customer service & manufacturer: neither the "clear" domes nor any other type of domes contains latex.

• Brand Name: GN RESOUND
• Common Device Name: PZ861-DRWC,PREZA 8
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, copenhagen 2750 ; DA 2750
• MDR Report Key: 10947943
• Report Number: 3005650109-2020-00050
• Device Sequence Number: 18972483
• Product Code: OSM
• UDI-Device Identifier: 05708296171019
• UDI-Public: 05708296171019
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2020

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,PREZA 8
• Device Catalogue Number: 20928608
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 12/04/2020
• 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