MAUDE Adverse Event Report: COCHLEAR LIMITED COCHLEAR OSIA OSI200 IMPLANT; COCHLEAR¿ OSIA¿ SYSTEM

Model Number OSI200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hematoma (1884); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on june 09, 2023.

Event Description

Per the clinic, the patient experiecned an infection at the implant site and was treated with antibiotics (specific type and duration not reported).The implanted device remains.Additional informatrion has been requested but not made available at the time of this report.

Manufacturer Narrative

Per the clinic, the patient underwent a drainage of the hematoma (specific date not reported).The implanted device remains.This report is submitted on june 19, 2023.

• Brand Name: COCHLEAR OSIA OSI200 IMPLANT
• Type of Device: COCHLEAR¿ OSIA¿ 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: kalai tamilselvan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 17096099
• MDR Text Key: 316840375
• Report Number: 6000034-2023-01747
• Device Sequence Number: 1
• Product Code: PFO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: OSI200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2023
• 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: Female