MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-24 for CARDIOCEL UNKNOWN manufactured by Admedus Regen Pty Ltd.
Report Number | 3010805634-2019-00001 |
MDR Report Key | 9367264 |
Date Received | 2019-11-24 |
Date of Report | 2019-11-23 |
Date of Event | 2017-01-01 |
Date Mfgr Received | 2018-08-25 |
Date Added to Maude | 2019-11-24 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | MRS. SEONA ROBERTS |
Manufacturer Street | 26 HARRIS ROAD |
Manufacturer City | MALAGA, WESTERN AUSTRALIA 6090 |
Manufacturer Country | AS |
Manufacturer Postal | 6090 |
Manufacturer G1 | ADMEDUS REGEN PTY LTD |
Manufacturer Street | 26 HARRIS ROAD |
Manufacturer City | MALAGA, WESTERN AUSTRALIA 6090 |
Manufacturer Country | AS |
Manufacturer Postal Code | 6090 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 0 |
Brand Name | CARDIOCEL |
Generic Name | INTRACARDIAC PATCH |
Product Code | DXZ |
Date Received | 2019-11-24 |
Model Number | UNKNOWN |
Catalog Number | UNKNOWN |
Lot Number | UNKNOWN |
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, WESTERN AUSTRALIA 6090 AS 6090 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization | 2019-11-24 |