MAUDE Adverse Event Report: COCHLEAR LTD CP1000 PROCESSING UNIT BULK, GREY; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Skin Irritation (2076)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on may 12 2020.

Event Description

Per the clinic, the device was rubbing against the patient's ear and the patient subsequently developed an infection.Clinical management is ongoing.

• Brand Name: CP1000 PROCESSING UNIT BULK, GREY
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer (Section G): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: kohilah nadaraja ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 10045872
• MDR Text Key: 190606764
• Report Number: 6000034-2020-01268
• 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
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Date Manufacturer Received: 04/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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