MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM PFP0.8X8 manufactured by Cryolife, Inc..
[182956092]
Upper middle aged male with history of carotid artery stenosis, hypertension and peripheral vascular disease. When the surgeon went to use the cryolife, photofix decellularized bovine pericardium patch, he was unable to identify rough side from the smooth side. Therefore, unable to use for procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9817827 |
| MDR Report Key | 9817827 |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-26 |
| Report Date | 2020-02-27 |
| Date Reported to FDA | 2020-02-27 |
| Date Reported to Mfgr | 2020-03-11 |
| Date Added to Maude | 2020-03-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PHOTOFIX DECELLULARIZED BOVINE PERICARDIUM |
| Generic Name | INTRACARDIAC PATCH OR PLEDGET, BIOLOGICALLY DERIVED |
| Product Code | PSQ |
| Date Received | 2020-03-11 |
| Returned To Mfg | 2020-02-28 |
| Model Number | PFP0.8X8 |
| Catalog Number | PFP0.8X8 |
| Lot Number | 31120519 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |