MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2016-06-30 for NEURAGEN NERVE GUIDE 6MM ID X 3CM LENGTH PNG630 manufactured by Integra Lifesciences Corporation.
[48521408]
It is reported a device in consignment was used on (b)(6) 2016 but the device implanted had an expiry date of 30apr2016. No patient impact information provided.
Patient Sequence No: 1, Text Type: D, B5
[67462704]
Integra has completed their internal investigation on 01/20/2017. The investigation activities included: methods: review of device history records. Review of complaint history. Results: the finished goods lot 1141379, catalog png630? (b)(4), was manufactured on 04/07/14 and its expiration date was 2016-04. The reported finished goods product lot associated with this complaint is neuragen nerve guide lot # 1141379 (anasco lot) for which the corresponding cmc plainsboro lot# is 105000300232. This product lot stems from the dispersion lot 105000300231. All testing met requirements, and were acceptable. Zero complaint of the same nature have been received for the past year (0 complaint / product uses). This is not statistically adverse when compared to the complaint rate for the prior time period (0 complaint / product uses). Conclusion: based on the investigation performed by integra, the complaint reported by the european hospital of marseille is not confirmed. As per the consignment contract signed between the customer and integra, this is the responsibility of the customer to manage expiry dates. Moreover, regardless of the contract, this is the responsibility of the hospital to check the implant (expiry date included) before implanting it into the patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2016-00013 |
| MDR Report Key | 5761264 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2016-06-30 |
| Date of Report | 2016-06-10 |
| Date of Event | 2016-06-08 |
| Date Mfgr Received | 2017-01-20 |
| Device Manufacturer Date | 2014-04-07 |
| Date Added to Maude | 2016-06-30 |
| 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 |
| Reporter Occupation | AUDIOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER MARIA LEONARD |
| 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 | 2016-06-30 |
| Catalog Number | PNG630 |
| Lot Number | 1141379 |
| Device Expiration Date | 2016-04-30 |
| 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 | 2016-06-30 |