MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-30 for NEUROFLEX CNCF3025 manufactured by Collagen Matrix, Inc..
[37489235]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2249852-2016-00003 |
| MDR Report Key | 5400133 |
| Date Received | 2016-01-30 |
| Date of Report | 2016-01-29 |
| Date of Event | 2016-01-08 |
| Date Mfgr Received | 2016-01-14 |
| Device Manufacturer Date | 2015-03-23 |
| Date Added to Maude | 2016-01-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. GLORIA ZUCLICH |
| Manufacturer Street | 15 THORNTON ROAD |
| Manufacturer City | OAKLAND NJ 07436 |
| Manufacturer Country | US |
| Manufacturer Postal | 07436 |
| Manufacturer Phone | 2014051477 |
| Manufacturer G1 | COLLAGEN MATRIX, INC. |
| Manufacturer Street | 15 THORNTON ROAD |
| Manufacturer City | OAKLAND NJ 07436 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07436 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEUROFLEX |
| Generic Name | NERVE CUFF |
| Product Code | JXI |
| Date Received | 2016-01-30 |
| Model Number | CNCF3025 |
| Lot Number | 1503151032 |
| Device Expiration Date | 2018-03-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COLLAGEN MATRIX, INC. |
| Manufacturer Address | 15 THORNTON ROAD OAKLAND NJ 07436 US 07436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-30 |