MAUDE Adverse Event Report: COCHLEAR LIMITED CP1150 MAGNET (STRENGTH 2 (I)); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP1150

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Erythema (1840)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on june 27, 2023.

Event Description

Per the clinic, the patient experienced redness and subsequently was treated with a topical steroid (specific date and duration not reported).

Manufacturer Narrative

Correction: the correct date of this report (b4) and date received by manufacturer (g3) is june 16, 2023; not may 01, 2023 as previously reported.This report is submitted on july 24, 2023.

• Brand Name: CP1150 MAGNET (STRENGTH 2 (I))
• 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: yaneesa vetsandonphong ; unit ug-1, vertical podium; no.8 jalan kerinchi; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17206220
• MDR Text Key: 317899530
• Report Number: 6000034-2023-02203
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP1150
• Device Catalogue Number: P1540173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2023
• 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 Sex: Male