MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION NEURAGEN NERVE GUIDE 5MM ID X 2CM LENGTH

Catalog Number PNG520

Device Problem Device Expiration Issue (1216)

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

Event Type  malfunction  

Event Description

It is reported; the distributor received a phone call from the customer regarding the use of the neuragen device that was implanted in (b)(6) 2014.The expiration date was (later) noted to be (b)(6) 2014.Additional information has been requested.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.

• Brand Name: NEURAGEN NERVE GUIDE 5MM ID X 2CM LENGTH
• Type of Device: NEURAGEN
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION; plainsboro NJ 08536
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4355941
• MDR Text Key: 5178697
• Report Number: 3003418325-2014-00011
• Device Sequence Number: 1
• Product Code: JXI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: PNG520
• Device Lot Number: 1125173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2014
• Was Device Evaluated by Manufacturer?: No
• 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