MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-04-19 for NEURAGEN NERVE GUIDE 2MM ID X 3CM LENGTH PNG230 manufactured by Integra Lifesciences Corporation.
[73102581]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[73102582]
It was reported that the product was grafted on (b)(6) 2017 and on (b)(6), the patient presented in medical office with an infection and revision/medical intervention was required. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[75846623]
Integra has completed their internal investigation on may 2, 2017. Results: the unit will not be returned for evaluation since it was implanted in the patient and has not been removed. As per evaluation of the ten (10) retain sample units no anomalies were observed. All units met product and packaging specifications. Dhr review; no anomalies were reported during the packaging process of this lot that could be related to the reported condition. Complaints history; since april 2015 to april 2017, only one (1) complaint (the one being investigated) related to? Neuragen infection? Has been reported in the neuragen family at integra. (b)(4). Conclusion: the reported condition described as? Neuragen infection? Could not be confirmed to be related to neuragen manufacturing or packaging process because there are controls in place during the process such as gowning, controlled areas, area and product monitoring, and validated sterilization cycles to prevent this type of events. Therefore, it is not possible to determine a root cause for the reported condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2017-00007 |
| MDR Report Key | 6502947 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-04-19 |
| Date of Report | 2017-03-27 |
| Date Mfgr Received | 2017-05-02 |
| Date Added to Maude | 2017-04-19 |
| 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 | USER SONIA IRIZARRY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Street | 105 MORGAN LANE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURAGEN NERVE GUIDE 2MM ID X 3CM LENGTH |
| Generic Name | NEURAGEN |
| Product Code | JXI |
| Date Received | 2017-04-19 |
| Catalog Number | PNG230 |
| Lot Number | 1160273 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-19 |