MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-01-05 for NEURAGEN NERVE GUIDE 6MM ID X 3CM LENGTH PNG630 manufactured by Integra Lifesciences Corporation.
[63951143]
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
[63951144]
It was reported that an expired product was implanted on a (b)(6) female. Patient was not injured and no adverse effects has been reported. The device will remain implanted. Patient is aware of the expired product.
Patient Sequence No: 1, Text Type: D, B5
[65919083]
Integra has completed their internal investigation on january 20, 2017. The investigation included: methods: review of device history records. Review of complaints history. Results: the unit will not be returned since it was implanted in the patient. Dhr review; ten (10) retain sample units were visually inspected for product and packaging appearance, including labeling. No anomalies were observed. All units met product and packaging specifications according to? Packaged collagen product inspection?. Complaints history; no similar complaints related to? Expired product implanted? Have been reported for this fg lot 1140945. Approximately (b)(4) units of neuragen products have been shipped for sales purposes since december 2014 until december 2016, resulting in a complaint occurrence rate of approximately(b)(4). Conclusion: (root/cause) the reported incident (expired product implanted) could not be associated to the manufacturing / packaging process performed. Complaint unit was labeled in an accurate manner and applicable procedures. The packaged product had several labels that contained the expiration date that are very noticeable by the end user, therefore the reported incident could be associated to inappropriate handling of the product (product misuse) by the reporting facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2016-00023 |
| MDR Report Key | 6224882 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-01-05 |
| Date of Report | 2016-12-19 |
| Date of Event | 2016-12-16 |
| Date Mfgr Received | 2017-01-20 |
| Device Manufacturer Date | 2014-03-31 |
| Date Added to Maude | 2017-01-05 |
| 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 6MM ID X 3CM LENGTH |
| Generic Name | NEURAGEN |
| Product Code | JXI |
| Date Received | 2017-01-05 |
| Catalog Number | PNG630 |
| Lot Number | 1140945 |
| Device Expiration Date | 2016-03-01 |
| 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 LIFESCIENCES CORPORATION |
| Manufacturer Address | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-05 |