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

Model Number	PZ861-DRWC
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Irritation (1941); Wheal(s) (2241)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
S/n (b)(4), left.Manufacturing date 07/30/2019 for s/n (b)(4), left.
Event or Problem Description
Severe allergic reaction from the semi-open domes, scaling of the skin.End-user has seen a doctor twice.Antibiotics have been prescribed.Both ears were affected.

• Brand Name: RESOUND
• Common Device Name: PREZA 8
• Manufacturer (Section D): GN HEARING A/S; lautrupbjerg 7; ballerup, 2750 ; DA 2750
• MDR Report Key: 9581421
• Report Number: 3005650109-2020-00002
• Device Sequence Number: 14264069
• Product Code: OSM
• UDI-Device Identifier: 05708296170975
• UDI-Public: 05708296170975
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/13/2020

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2019
• Initial Report FDA Received Date: 01/13/2020
• 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