MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2018-02-26 for NEURAGEN NERVE GUIDE 6MM ID X 3CM LENGTH PNG630 manufactured by Integra Lifesciences Corp.
[101004328]
The device was not returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[101004329]
It was reported by a patient that sometime in (b)(6) 2017, a sudden infection on the surgical site where the collagen tube was placed almost 3 years ago. The patient had to undergo more surgery to combat the foreign object that was left in the surgical site. It was noted that the collagen had not dissolved, thus causing a sudden eruption, infection, and a need for surgery which requires 5 days hospitalization. No further patient complications has been noted. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2018-00011 |
| MDR Report Key | 7297837 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2018-02-26 |
| Date of Report | 2018-02-02 |
| Date of Event | 2017-11-01 |
| Date Mfgr Received | 2018-03-01 |
| Date Added to Maude | 2018-02-26 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER VIVIAN NELSON |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORP |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| 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 | NEURAGEN NERVE GUIDE 6MM ID X 3CM LENGTH |
| Generic Name | NEURAGEN |
| Product Code | JXI |
| Date Received | 2018-02-26 |
| Catalog Number | PNG630 |
| 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 | 311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2018-02-26 |