MAUDE Adverse Event Report: COCHLEAR LIMITED CP1110 PROCESSING UNIT (GREY); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP1110

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Unspecified Infection (1930); Skin Inflammation/ Irritation (4545)

Event Date 09/15/2023

Event Type  Injury  

Manufacturer Narrative

This report is submitted on (b)(6), 2023.

Event Description

Per the clinic, the patient experienced an irritation when using the device and subsequently was treated with two types of oral antibiotics, one on (b)(6), 2023 and another one on (b)(6), 2023.(specific duration not reported).

Manufacturer Narrative

Per the clinic, the patient experienced an infection at the sound processor site.This report is submitted on november 28, 2023.

• Brand Name: CP1110 PROCESSING UNIT (GREY)
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LIMITED; 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: thevamalar jayamagentharan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18027716
• MDR Text Key: 326789827
• Report Number: 6000034-2023-03498
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP1110
• Device Catalogue Number: P1840542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2023
• 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
• Patient Age: 52 YR