MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-09 for NEURAGEN NERVE GUIDE 3MM ID X 2CM LENGTH PNG320 manufactured by Integra Neurosciences Pr.
[97857286]
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
[97857287]
It was reported by the account manager that a png320 neuragen was used on (b)(6) 2017 and later found out that the product was expired. There was no information provided regarding patient consequences or delay in the surgery. Attempts to obtain additional information was unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648988-2018-00001 |
| MDR Report Key | 7175395 |
| Date Received | 2018-01-09 |
| Date of Report | 2017-12-12 |
| Date of Event | 2017-11-26 |
| Date Mfgr Received | 2018-01-19 |
| Device Manufacturer Date | 2015-08-09 |
| Date Added to Maude | 2018-01-09 |
| 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 VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA NEUROSCIENCES PR |
| Manufacturer Street | ROAD 402 NORTH, KM 1.2 |
| Manufacturer City | ANASCO PR 00610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEURAGEN NERVE GUIDE 3MM ID X 2CM LENGTH |
| Generic Name | NEURAGEN |
| Product Code | JXI |
| Date Received | 2018-01-09 |
| Catalog Number | PNG320 |
| Lot Number | 1153468 |
| Device Expiration Date | 2017-08-01 |
| 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 NEUROSCIENCES PR |
| Manufacturer Address | ROAD 402 NORTH, KM 1.2 ROAD 402 NORTH, KM 1.2 ANASCO PR 00610 US 00610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-09 |