MAUDE Adverse Event Report: COCHLEAR LTD CP900 SERIES MAGNET (3M, CARBON); NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number CP900 MAGNET

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Skin Erosion (2075)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Per the clinic, the patient experienced skin breakdown behind the ear in (b)(6) 2019.The patient was treated with topical antibiotic ointment.

• Brand Name: CP900 SERIES MAGNET (3M, CARBON)
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, 2109 ; AS 2109
• Manufacturer Contact: yi feng ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 8733355
• MDR Text Key: 149159835
• Report Number: 6000034-2019-01020
• 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
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CP900 MAGNET
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2019
• 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