MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-29 for MACI 81074 manufactured by Vericel.
| Report Number | 3002836339-2020-00002 |
| MDR Report Key | 9640614 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-28 |
| Date of Event | 2019-12-30 |
| Date Mfgr Received | 2019-12-30 |
| Date Added to Maude | 2020-01-29 |
| 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 Street | 64 SIDNEY STREET |
| Manufacturer City | CAMBRIDGE MA 02139 |
| Manufacturer Country | US |
| Manufacturer Postal | 02139 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MACI |
| Generic Name | CARTILAGE BIOMATRIX IMPLANT |
| Product Code | NCO |
| Date Received | 2020-01-29 |
| Model Number | 81074 |
| Lot Number | BB12854 |
| Device Expiration Date | 2020-01-20 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERICEL |
| Manufacturer Address | 64 SIDNEY STREET CAMBRIDGE MA 02139 US 02139 |
| Brand Name | MACI |
| Product Code | --- |
| Date Received | 2020-01-29 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | VERICEL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-29 |