MAUDE Adverse Event Report: COCHLEAR LIMITED CP1150 SOUND PROCESSOR (BLACK) - SINGLE PACK; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP1150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Type  Injury  

Event Description

Per the clinic, the patient reported skin near the processor site was sore and blistered.Subsequently, the patient was treated with topical cream (specific 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

This report is submitted on april 22, 2022.

Manufacturer Narrative

Per the clinic, the patient was treated with oral and topical antibiotics (specific date and duration not reported).This report is submitted on may 24, 2022.

• Brand Name: CP1150 SOUND PROCESSOR (BLACK) - SINGLE PACK
• 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: aini yusof ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 14184197
• MDR Text Key: 289853395
• Report Number: 6000034-2022-01306
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP1150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2022
• 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
• Patient Sex: Male