MAUDE Adverse Event Report: COCHLEAR LTD COCHLEAR OSIA OSI300 IMPLANT; COCHLEAR¿ OSIA¿ SYSTEM

Model Number OSI300

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Impaired Healing (2378)

Event Type  Injury  

Event Description

Per the clinic, the patient was treated with oral and topical antibiotics (specific date and duration not reported) due to improper wound healing issue at the transducer (specific date not reported).

Manufacturer Narrative

This report is submitted on november 23, 2023.

• Brand Name: COCHLEAR OSIA OSI300 IMPLANT
• Type of Device: COCHLEAR¿ OSIA¿ SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 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: thanaletchumi manogaran ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 18197003
• MDR Text Key: 328885301
• Report Number: 6000034-2023-03785
• Device Sequence Number: 1
• Product Code: PFO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K231204
• 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: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: OSI300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2023
• 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