MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-03 for CANGAROO ENVELOPE CMCV-009-XXL manufactured by Aziyo Biologics, Inc..
[188190329]
Device lot number is unknown. Manufacturing review of the device history record cannot be conducted. Although the exact cause of the reported event cannot be conclusively determined, hematoma is a known complication with the cangaroo envelope as stated in the ifu provided with the device.
Patient Sequence No: 1, Text Type: N, H10
[188190330]
It was reported that reimplant was done for the patient's device. Patient had hematoma. Device was placed submuscular versus previously intramuscular position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005619880-2020-00019 |
| MDR Report Key | 9781251 |
| Report Source | OTHER |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-02 |
| Date Mfgr Received | 2020-02-05 |
| Date Added to Maude | 2020-03-03 |
| 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 | 2020-03-03 |
| Model Number | CMCV-009-XXL |
| 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 | 2020-03-03 |