MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,study report with the FDA on 2019-11-25 for CARDIOCEL EC0404 manufactured by Admedus Regen Pty Ltd.
| Report Number | 3010805634-2019-00005 |
| MDR Report Key | 9367799 |
| Report Source | FOREIGN,STUDY |
| Date Received | 2019-11-25 |
| Date of Report | 2019-11-24 |
| Date of Event | 2018-02-15 |
| Date Mfgr Received | 2017-11-23 |
| Date Added to Maude | 2019-11-25 |
| 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 | MS. SEONA ROBERTS |
| Manufacturer Street | 26 HARRIS ROAD |
| Manufacturer City | MALAGA, WEST AUSTRALIA 6090 |
| Manufacturer Country | AS |
| Manufacturer Postal | 6090 |
| Manufacturer G1 | ADMEDUS REGEN PTY LTD |
| Manufacturer Street | 26 HARRIS ROAD |
| Manufacturer City | MALAGA, WEST AUSTRALIA 6090 |
| Manufacturer Country | AS |
| Manufacturer Postal Code | 6090 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOCEL |
| Generic Name | CARDIOVASCULAR PATCH |
| Product Code | DXZ |
| Date Received | 2019-11-25 |
| Model Number | EC0404 |
| Catalog Number | EC0404 |
| Lot Number | M15058-28-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADMEDUS REGEN PTY LTD |
| Manufacturer Address | 26 HARRIS ROAD MALAGA, WEST AUSTRALIA 6090 AS 6090 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-25 |