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-010-XLG manufactured by Aziyo Biologics, Inc..
[188139544]
Manufacturing review of the device history record for the reported lot shows that all units were quality released on 9/9/2019 having met all internal qc acceptance requirements. All sterilization records, and bioburden testing indicate successful sterilization process, and passing lal and product sterility results allowed the lot to be released having met all criteria for manufacturing release. There were no non-conformances associated with the manufacturing lot during production, sterilization and final packaging. In lieu of a request for the oem supplier dhr review, it is noted that aziyo processes the non-sterile envelope materials by cutting, suturing, packaging, and sterilizing. It can be noted that per the instructions for use [ifu] (part number-20663 provided with device) for the cangaroo envelope currently lists infection as a potential complication associated with the procedure and device. Although the exact cause of the reported event cannot be conclusively determined, infection is a known complication with the cangaroo envelope.
Patient Sequence No: 1, Text Type: N, H10
[188139545]
Patient had pulse generator and leads explanted due to infection/sepsis. Aziyo product remains in service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005619880-2020-00022 |
| MDR Report Key | 9781984 |
| Report Source | OTHER |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-02-07 |
| Device Manufacturer Date | 2019-09-09 |
| 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 | 0 |
| 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-010-XLG |
| Lot Number | M19K1385002 |
| 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 |