MAUDE Adverse Event Report: COCHLEAR LTD CP920 PROCESSING UNIT (CARBON) REFURBISHED; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP900PU

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Irritation (2076)

Event Type  Injury  

Event Description

Per the clinic, the patient developed skin irritation at the implant site with use of the external processor.Antibiotics were prescribed (type not reported) to treat the irritation.

• Brand Name: CP920 PROCESSING UNIT (CARBON) REFURBISHED
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• MDR Report Key: 9080208
• MDR Text Key: 160489778
• Report Number: 6000034-2019-01891
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/18/2019,09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP900PU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/18/2019
• Distributor Facility Aware Date: 09/09/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention