MAUDE Adverse Event Report: COCHLEAR LIMITED ASKU; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number ASKU

Device Problems No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on february 24,2022.

Event Description

Per the clinic, the patient experienced pain (specific date not reported) and subsequently was treated with antibiotics (specific type, date and duration not reported).Additional information has been requested but has not been made available as of the date of this report.

Manufacturer Narrative

The previous or initial mdr submitted on february 24, 2022 was filed inadvertently.No device malfunction/explantation or serious injury has occurred.This report is submitted on march 21, 2022.

• Brand Name: ASKU
• 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: 13589531
• MDR Text Key: 286043148
• Report Number: 6000034-2022-00731
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 03/21/2022
• 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