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

Model Number CI-1601-04

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

Patient Problems Irritation (1941); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Event Description

The recipient is reportedly experiencing irritation and soreness at the incision site.The recipient was prescribed a topical antibiotic cream which is improving the site.

Manufacturer Narrative

The recipient's incision is reportedly healing nicely.The recipient was recommended to continue using the topical antibiotic cream.The recipient continues to wear the device consistently.

Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed.The recipient's site has reportedly healed.This is the final report.

• Brand Name: HIRES¿ ULTRA 3D IMPLANT
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): ADVANCED BIONICS, LLC; 28515 westinghouse place; valencia CA 91355
• Manufacturer Contact: lacey mcdonald ; 28515 westinghouse place; valencia, CA 91355
• MDR Report Key: 8592213
• MDR Text Key: 144460461
• Report Number: 3006556115-2019-00223
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 07630016862250
• UDI-Public: (01)07630016862250(11)190204(17)220131
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/15/2019

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Model Number: CI-1601-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/04/2019; 07/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2019
• 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