MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-12-17 for NEURAGEN NERVE GUIDE 5MM ID X 2CM LENGTH PNG520 manufactured by Integra Lifesciences Corporation.
[5178697]
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.
Patient Sequence No: 1, Text Type: D, B5
[12626707]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003418325-2014-00011 |
| MDR Report Key | 4355941 |
| Report Source | 08 |
| Date Received | 2014-12-17 |
| Date of Report | 2014-11-20 |
| Date Mfgr Received | 2014-11-20 |
| Date Added to Maude | 2015-01-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURAGEN NERVE GUIDE 5MM ID X 2CM LENGTH |
| Generic Name | NEURAGEN |
| Product Code | JXI |
| Date Received | 2014-12-17 |
| Catalog Number | PNG520 |
| Lot Number | 1125173 |
| Device Expiration Date | 2014-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-17 |