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 CORMATRIX ECM FOR CARDIAC TISSUE REPAIR CMCV-004-401 manufactured by Aziyo Biologics, Inc..
| Report Number | 3005619880-2019-00008 |
| MDR Report Key | 8870610 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-08-07 |
| Date of Report | 2019-08-07 |
| Date of Event | 2019-06-04 |
| Date Mfgr Received | 2019-07-09 |
| Device Manufacturer Date | 2015-06-03 |
| 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 | MR. ANDREW GREEN |
| Manufacturer Street | 1100 OLD ELLIS ROAD STE 1200 |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer G1 | AZIYO BIOLOGICS, INC. |
| Manufacturer Street | 1100 OLD ELLIS ROAD STE 1200 |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30076 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORMATRIX ECM FOR CARDIAC TISSUE REPAIR |
| Generic Name | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE |
| Product Code | DXZ |
| Date Received | 2019-08-07 |
| Returned To Mfg | 2019-06-12 |
| Model Number | CMCV-004-401 |
| Lot Number | M15F1133 |
| Device Expiration Date | 2016-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AZIYO BIOLOGICS, INC. |
| Manufacturer Address | 1100 OLD ELLIS ROAD STE 1200 ROSWELL GA 30076 US 30076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-08-07 |