MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-05 for ARTEGRAFT REF # AG 840 manufactured by Artegraft.
| Report Number | 9323713 |
| MDR Report Key | 9323713 |
| Date Received | 2019-11-05 |
| Date of Report | 2019-10-31 |
| Date of Event | 2019-10-28 |
| Date Facility Aware | 2019-10-28 |
| Report Date | 2019-10-31 |
| Date Reported to FDA | 2019-10-31 |
| Date Reported to Mfgr | 2019-10-01 |
| Date Added to Maude | 2019-11-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARTEGRAFT |
| Generic Name | BOVINE CAROTID ARTERY GRAFT |
| Product Code | LXA |
| Date Received | 2019-11-05 |
| Model Number | REF # AG 840 |
| Lot Number | 19D109-047 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTEGRAFT |
| Manufacturer Address | 206N CENTER DR NORTH BRUNSWICK TWP NJ 08902 US 08902 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-11-05 |