MAUDE Adverse Event Report: COCHLEAR LTD COCHLEAR OSIA OSI200 IMPLANT; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number OSI200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on may 20, 2021.

Event Description

Per the clinic, the patient experienced skin breakdown over the implant site and was subsequently explanted on (b)(6) 2021.The patient was administered oral antibiotic for 10 days to avoid infection.

Manufacturer Narrative

This report is submitted on august 6, 2021.

• Brand Name: COCHLEAR OSIA OSI200 IMPLANT
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university; nsw 2109 ; AS 2109
• MDR Report Key: 11854432
• MDR Text Key: 251651363
• Report Number: 6000034-2021-01473
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502046152
• UDI-Public: (01)09321502046152(11)201209(17)221208
• Combination Product (y/n): N
• PMA/PMN Number: K190589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2022
• Device Model Number: OSI200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention