MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-03-07 for NEURAGEN NERVE GUIDE 6MM ID X 2CM LENGTH PNG620 manufactured by Integra Lifesciences Corp..
[18728797]
This is the first of two reports concerning the same pt. This report concerns neuragen. It was reported the customer asked if there were any adverse events reported regarding allergic reactions regarding neuragen. Add'l info was received from the medical assistant: 'on (b)(6) 2013 the surgeon performed a neurolysis of the right median nerve on a (b)(6) female for a recurrent carpal tunnel syndrome. The pt experienced an improvement in numbness in a post-operative visit to the doctor in (b)(6) 2013. The pt experienced pain, soreness and swelling in (b)(6) 2013 and was received a joint injection (unspecified) and was put in a cast. The pt has had a questionable allergic reaction. She had symptoms of an atypical infection with continued pain and swelling. She had extensive treatment with an infectious disease physician that consisted of iv antibiotics which resulted in no change of symptoms. She still has swelling at the carpal tunnel where the implant is and swelling on the flexor side of the right thumb. Pt had x-rays and an mri study. X-rays showed a strange calcification at the volar aspect of the proximal phalanx. She did undergo a biopsy of the bone and it was sampled for cultures. At this time the pt continues to have swelling of the thumb and wrist'. Add'l info was requested by integra.
Patient Sequence No: 1, Text Type: D, B5
[18766408]
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 | 1121308-2014-00009 |
| MDR Report Key | 3677288 |
| Report Source | 05,07 |
| Date Received | 2014-03-07 |
| Date of Report | 2014-02-13 |
| Date Mfgr Received | 2014-02-13 |
| Date Added to Maude | 2014-03-14 |
| 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 | NEURAGEN NERVE GUIDE 6MM ID X 2CM LENGTH |
| Generic Name | NEURAGEN |
| Product Code | JXI |
| Date Received | 2014-03-07 |
| Catalog Number | PNG620 |
| Lot Number | 1125382 |
| 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 | 2014-03-07 |