MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES¿ 3D ULTRA IMPLANT; COCHLEAR IMPLANT

Model Number CI-1601-04

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Breakdown (2681); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

Event Description

The recipient was reportedly prescribed an ointment to treat a scab at the implant site.The recipient was advised to discontinue use until further notice.The recipient continues to be monitored.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly experienced skin flap breakdown prior to developing a scab.The recipient was diagnosed with scalp seborrheic dermatitis.The recipient's issues have since resolved.External equipment was exchanged and the recipient has resumed device use.Additional treatment details will not be provided.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.

• Brand Name: HIRES¿ 3D ULTRA IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: alexandra gonzalez ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 15156834
• MDR Text Key: 297154515
• Report Number: 3006556115-2022-01175
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016877995
• UDI-Public: (01)07630016877995(11)210713(17)240630
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CI-1601-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male