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

Model Number OSI200

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Unspecified Infection (1930)

Event Date 04/22/2021

Event Type  Injury  

Manufacturer Narrative

This report is submitted on april 30, 2021.

Event Description

Per the clinic, the patient developed an infection and was treated with oral antibiotics (date and duration not reported).The patient underwent a revision surgery on (b)(6) 2021, to revise the skin and re-position the device.Clinical management is ongoing.The implanted device remains.

• Brand Name: COCHLEAR OSIA OSI200 IMPLANT
• Type of Device: COCHLEAR¿ OSIA¿ SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: weiting zhen ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 11751111
• MDR Text Key: 248164913
• Report Number: 6000034-2021-01256
• Device Sequence Number: 1
• Product Code: PFO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191921
• 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: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• 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: 04/07/2021
• 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 Age: 5 YR