MAUDE Adverse Event Report: COCHLEAR LTD BA400 ABUTMENT 10MM; NUCLEUS 24 COCHLEAR IMPLANT SYSTEM

Model Number 93335

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Host-Tissue Reaction (1297)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on august 17, 2018.

Event Description

Per the surgeon, the patient experienced skin overgrowth at the abutment site.Subsequently the patient underwent a skin revision during an abutment change (date not reported).

• Brand Name: BA400 ABUTMENT 10MM
• Type of Device: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
• Manufacturer (Section D): COCHLEAR LTD; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• Manufacturer Contact: sujeewa wijesinghe ; 1 university avenue; macquarie university, nsw 2109 ; AS 2109
• MDR Report Key: 7792253
• MDR Text Key: 117419571
• Report Number: 6000034-2018-01712
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09321502022750
• UDI-Public: (01)09321502022750(10)140055(17)180630
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Model Number: 93335
• Device Catalogue Number: 93335
• Device Lot Number: 140055
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2018
• 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