MAUDE Adverse Event Report: COCHLEAR LTD UNKNOWN; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Manufacturer Narrative

Device details unavailable at the time of this report.(b)(4).

Event Description

It was reported that the patient experienced an alleged 'burn' with use of the external processor.The device has not been returned to the manufacturer.Additional information had been requested but not made available at the time of this report.

Manufacturer Narrative

This report is filed on march 03, 2017.

• Brand Name: UNKNOWN
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: kristel kohne ; 1 university avenue; macqaurie university, nsw 2109 ; AS 2109 ; 94286555
• MDR Report Key: 6187987
• MDR Text Key: 62785261
• Report Number: 6000034-2016-02444
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention