MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-07-09 for AXOGUARD NERVE CONNECTOR AND PROTECTOR AG1040 manufactured by Cook Biotech.
| Report Number | 1835959-2019-00003 |
| MDR Report Key | 8771729 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-07-09 |
| Date of Report | 2019-07-09 |
| Date of Event | 2019-05-28 |
| Date Mfgr Received | 2019-06-19 |
| Device Manufacturer Date | 2018-12-01 |
| Date Added to Maude | 2019-07-09 |
| 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 | MR. PERRY GUINN |
| Manufacturer Street | 1425 INNOVATION PLACE |
| Manufacturer City | WEST LAFAYETTE IN 47906 |
| Manufacturer Country | US |
| Manufacturer Postal | 47906 |
| Manufacturer Phone | 7654973355 |
| Manufacturer G1 | COOK BIOTECH INCORPORATED |
| Manufacturer Street | 1425 INNOVATION PLACE |
| Manufacturer City | WEST LAFAYETTE IN 47906 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47906 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXOGUARD NERVE CONNECTOR AND PROTECTOR |
| Generic Name | NERVE PROTECTOR |
| Product Code | JXI |
| Date Received | 2019-07-09 |
| Catalog Number | AG1040 |
| Lot Number | LB1107477 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK BIOTECH |
| Manufacturer Address | 1425 INNOVATION PLACE WEST LAFAYETTE IN 47906 US 47906 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-09 |