MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. NEUROFLEX; NERVE CUFF

Model Number	CNCF3025
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Prior to device use, and after the product (3.0mm x 2.5cm neuroflex tube) was prepared/hydrated for use, a technician noticed that the device felt hard in the middle.The surgeon felt the device and observed that there seemed to be a hard plastic tube inside the product.The device was discarded and a new 2.5mm x 2.5cm device was used instead.The product in question was not returned to the manufacturer for further evaluation.

• Brand Name: NEUROFLEX
• Common Device Name: NERVE CUFF
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• MDR Report Key: 5400133
• Report Number: 2249852-2016-00003
• Device Sequence Number: 16270679
• Product Code: JXI
• UDI-Device Identifier: 00813954020082
• UDI-Public: 00813954020082
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K131541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Report Date (Section B): 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: CNCF3025
• Device Lot Number: 1503151032
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1