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-XLG manufactured by Aziyo Biologics, Inc..
[188138931]
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, infection 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
[188138932]
It was reported that this product was part of a system explant due to infection and erosion with sepsis. The patient was treated with intravenous antibiotics. There were no additional adverse patient effects reported. This product was explanted. Report states aziyo product not related to event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005619880-2020-00021 |
| MDR Report Key | 9781359 |
| Report Source | OTHER |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2019-10-04 |
| 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-XLG |
| 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 |