MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-02-06 for BOVINE PERICARDIAL PATCH 4700 NA manufactured by Edwards Lifesciences.
[21713040]
Reportedly, pt expired after an implant in 2006, due to unk reasons. Unk if pt death is device related. Date of pt's death and implant duration is unk, therefore, the aware date is used as the occurence date. No further info regarding this pt was received.
Patient Sequence No: 1, Text Type: D, B5
[21822453]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000002-2008-06005 |
| MDR Report Key | 993104 |
| Report Source | 05,06 |
| Date Received | 2008-02-06 |
| Date of Report | 2007-10-23 |
| Date of Event | 2007-10-23 |
| Date Mfgr Received | 2007-10-23 |
| Date Added to Maude | 2008-02-13 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | JODI TURPIN |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492502004 |
| Manufacturer G1 | EDWARDS LIFESCIENCES |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOVINE PERICARDIAL PATCH |
| Generic Name | PERICARDIAL PATCH |
| Product Code | MFX |
| Date Received | 2008-02-06 |
| Model Number | 4700 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 965690 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-02-06 |