MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-08-07 for EPICEL AU201 manufactured by Vericel Corporation.
| Report Number | 1226230-2019-00017 |
| MDR Report Key | 8869552 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-08-07 |
| Date of Report | 2019-08-07 |
| Date Mfgr Received | 2019-07-23 |
| Date Added to Maude | 2019-08-07 |
| 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 | LIZ GREKAS |
| Manufacturer Street | 64 SIDNEY STREET |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Manufacturer Phone | 6175885623 |
| Manufacturer G1 | VERICEL CORPORATION |
| Manufacturer Street | 64 SIDNEY STREET MA 02139 |
| Manufacturer City | CAMBRIDGE 02139 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02139 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EPICEL |
| Generic Name | EPICEL CULTURED EPIDERMAL AUTOGRAFTS |
| Product Code | OCE |
| Date Received | 2019-08-07 |
| Model Number | AU201 |
| Lot Number | EE02499 |
| Device Expiration Date | 2019-07-09 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERICEL CORPORATION |
| Manufacturer Address | 64 SIDNEY STREET CAMBRIDGE MA 02139 US 02139 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2019-08-07 |