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

Model Number CP1000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Eczema (4547)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on july 05, 2021.

Event Description

Per the clinic, the patient experienced severe eczema reaction behind the ear and subsequently was treated with oral antibiotics and steroid cream (date and duration not reported).

Manufacturer Narrative

It was reported the patient developed an infection subsequent to the eczema reaction previously reported.This report is submitted on july 30, 2021.

• Brand Name: CP1000 PROCESSING UNIT PACKED, SAND
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 12114935
• MDR Text Key: 259986157
• Report Number: 6000034-2021-02084
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP1000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention