MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-12-26 for NEURAWRAP NERVE PROTECTOR 5MM ID X 4CM LENGTH NW540 manufactured by Integra Lifesciences Corp..
[20715261]
It was reported there was "an adverse event with a prior use of neurawrap about 6-8 months ago. Upon re-entry to the nerve repair site where neurawrap was implanted, the implant site and surrounding area was "brownish" and slimy. " add'l clinical info was requested numerous times by integra.
Patient Sequence No: 1, Text Type: D, B5
[20871726]
The device involved in the reported incident is not available for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2013-00061 |
| MDR Report Key | 3557136 |
| Report Source | 05,07 |
| Date Received | 2013-12-26 |
| Date of Report | 2013-12-04 |
| Date Mfgr Received | 2013-12-04 |
| Date Added to Maude | 2014-01-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DR |
| 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 5MM ID X 4CM LENGTH |
| Generic Name | NEURAWRAP |
| Product Code | JXI |
| Date Received | 2013-12-26 |
| Catalog Number | NW540 |
| Lot Number | 1115969 |
| 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 | 2013-12-26 |