MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-24 for CANGAROO ENVELOPE manufactured by Aziyo Biologics, Inc.
| Report Number | 3005619880-2020-00029 |
| MDR Report Key | 9874272 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-24 |
| 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 |
| 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 |
| Manufacturer Country | US |
| Manufacturer G1 | AZIYO BIOLOGICS, INC |
| Manufacturer Street | 1100 OLD ELLIS ROAD STE 1200 |
| Manufacturer City | ROSWELL, GA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CANGAROO ENVELOPE |
| Generic Name | MESH, SURGICAL |
| Product Code | FTM |
| Date Received | 2020-03-24 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AZIYO BIOLOGICS, INC |
| Manufacturer Address | 1100 OLD ELLIS ROAD STE 1200 ROSWELL, GA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |