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 2016-02-25 for NEURAWRAP NERVE PROTECTOR 10MM ID X 2CM LENGTH NW1020 manufactured by Integra Lifesciences Corporation.
[39079309]
It was reported a charge sheet was created/processed on (b)(6) 2016, used (1) piece of nw1020 with an expiration date of 31oct2015. The charge sheet indicates a surgery date of (b)(6) 2016. The product was confirmed to be used on a patient. It was reported the patient was not harmed and no efforts have been made to explant the implanted device.
Patient Sequence No: 1, Text Type: D, B5
[48010781]
Integra completed its internal investigation 7jun2016. The investigation included: method: review of device history records. Review of complaint management database for similar complaints. Results: according to the dhr review, no anomalies were reported during the packaging process of this lot that could be related to the reported condition. Finished goods (fg) lot 1134428 was released on 11/15/13 and its expiration date is 2015-10. No similar complaints related to? Use of expired product? Have been reported for this fg lot 1134428. After reviewing the complaint system since 01/01/13 until 02/11/16, (b)(4) complaints (including the one being investigated) related to? Use of expired product? Have been reported. Approximately (b)(4) units of neurawrap products have been shipped for sales purposes since 2013 until 02/11/16, resulting in a complaint occurrence rate of approximately (b)(4). Conclusion: based on information provided on the complaint record and the failure analysis that was made taking into account the retain samples evaluation, the reported incident (use of expired product) could not be associated (confirmed) to the manufacturing / packaging process performed at integra (b)(4). Complaint unit was labeled in an accurate. The reported incident could be associated to the handling of the product (product misuse) at the reporting facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2016-00005 |
| MDR Report Key | 5461112 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2016-02-25 |
| Date of Report | 2016-02-10 |
| Date of Event | 2016-02-04 |
| Date Mfgr Received | 2016-06-07 |
| Device Manufacturer Date | 2013-11-15 |
| Date Added to Maude | 2016-02-25 |
| 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 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 | NEURAWRAP NERVE PROTECTOR 10MM ID X 2CM LENGTH |
| Generic Name | NEURAWRAP |
| Product Code | JXI |
| Date Received | 2016-02-25 |
| Catalog Number | NW1020 |
| Lot Number | 1134428 |
| Device Expiration Date | 2015-10-31 |
| 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 | 2016-02-25 |