MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-08-02 for NEURAWRAP NERVE PROTECTOR 7MM ID X 4CM LENGTH NW740 manufactured by Integra Lifesciences Corp..
[3711052]
It was reported a pt presented with reactions potentially due to neurawrap following revision carpal tunnel and cubital tunnel surgery. Additional info was reported by the surgeon: "the pt experienced pain in the carpal tunnel area, as well as the wrist post surgery. She presented at two weeks post-surgery with inflamed skin over the cubital tunnel that looked as if it was an "abscess. " a small incision was made and the implant looked as though it had just been placed. No odor and no pus. The extruded material was described as grey gelatinous material just like that found in a rheumatoid joint. The pt responded to the steroid treatment and the small exploratory incision at the wrist, is closing well. The pt currently has a lump over the wrap used in the elbow. The surgeon reported this as reactive synovitis" and has decided not to remove the implants. He said he will wait and see if the problem resolves with the steroid treatment.
Patient Sequence No: 1, Text Type: D, B5
[10931570]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2013-00045 |
| MDR Report Key | 3284627 |
| Report Source | 05,07 |
| Date Received | 2013-08-02 |
| Date of Report | 2013-08-02 |
| Date Mfgr Received | 2013-07-10 |
| Date Added to Maude | 2013-08-26 |
| 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 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 | NEURAWRAP |
| Product Code | JXI |
| Date Received | 2013-08-02 |
| Catalog Number | NW740 |
| Lot Number | 1121852 |
| 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 CORP. |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-08-02 |