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

Model Number	PZ862-DRW,PREZA 8,GN RESOUND
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The underside of the preza 862 has a rectangular area cut out for the programming boot.This area has rubbed a sore spot.The user has a known history/weakness in this area with other hearing aids.We report this event as a hcp has been involved and medicine has been prescribed.There's stated no sign of scarring, so no permanent damage and this event is considered unlike to become a serious injury, should it recur.This is a final mdr report.
Event or Problem Description
As reported: programming port rubbed sore spot on back of ear.Unsure when it occurred.Hearing device was new in (b)(6) 2020 and is reporting issue now.The underside of the preza 62 device has the rectangular cut-out area for the programming boot.This woman has very thin skin and it has rubbed a sore spot on the back of her ear and she was seen by a physician for antibiotics.The store member reports that this has happened to this member in the past with other brands of hearing aids.Hcp is asking if there is a special work request were we could cover up the rectangular opening to make the back of the aid smooth.Member likes the sound quality of this aid.Member does not want the preza rechargable which is smooth.I told her i will need to check on options for modifying the case.I talked to (b)(6) her isr about options also.Complaint created interpretation: the underside of the preza 862 has a rectangular area cut out for the programming boot.This area has rubbed a sore spot.The user has a known history/weakness in this area with other hearing aids.We report this event as a hcp has been involved and medicine has been prescribed.There's stated no sign of scarring, so no permanent damage and this event is considered unlike to become a serious injury, should it recur.This is a final mdr report.

• 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: 10205206
• Report Number: 3005650109-2020-00020
• Device Sequence Number: 2641131
• Product Code: OSM
• UDI-Device Identifier: 05708296160570
• UDI-Public: 05708296160570
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2020

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: PZ862-DRW,PREZA 8,GN RESOUND
• Device Catalogue Number: 20959905
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 06/29/2020
• 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