MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-02-05 for NEURAWRAP NERVE PROTECTOR 7MM ID X 4CM LENGTH NW740 manufactured by Integra Lifesciences Corp..
[5446807]
It was reported a patient presented with swelling at the surgical site following a procedure where the neurawrap product was implanted. Additional information received by return phone call from the surgeon: the neurawrap product was used for a carpal tunnel procedure. The patient had excessive synovial fluid drainage following the procedure. The surgeon believes this is due to the neurawrap product specifically. The swelling was treated with prednisone and anti-inflammatory agents. The surgeon believes this complication is due to a reaction to the neurawrap. There was no infection.
Patient Sequence No: 1, Text Type: D, B5
[12885082]
The device will not be returned since it remains implanted. Based on reported information, integra has initiated an investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2015-00006 |
| MDR Report Key | 4503125 |
| Report Source | 05 |
| Date Received | 2015-02-05 |
| Date of Report | 2015-01-12 |
| Date of Event | 2014-12-20 |
| Date Mfgr Received | 2015-01-12 |
| Date Added to Maude | 2015-03-11 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEURAWRAP NERVE PROTECTOR 7MM ID X 4CM LENGTH |
| Generic Name | NA |
| Product Code | JXI |
| Date Received | 2015-02-05 |
| Catalog Number | NW740 |
| Lot Number | 1143743 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP. |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-02-05 |