MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP. NEURAGEN NERVE GUIDE 3MM ID X 3CM LENGTH

Lot Number 1121506

Device Problem Shelf Life Exceeded (1567)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2014

Event Type  Other  

Event Description

It was reported by the nurse that a hand surgeon implanted expired neuragen in a pt during surgery.

Manufacturer Narrative

The device involved in the reported incident is not available for eval.An investigation has been initiated based upon the reported info.

• Brand Name: NEURAGEN NERVE GUIDE 3MM ID X 3CM LENGTH
• Type of Device: NEURAGEN
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORP.; plainsboro NJ 08536
• Manufacturer Contact: caren finkelstein ; 315 enterprise dr; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 3919522
• MDR Text Key: 4664571
• Report Number: 1121308-2014-00019
• Device Sequence Number: 1
• Product Code: JXI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011168
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Lot Number: 1121506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other