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.
[21395714]
Reportedly, pt expired approximately after an implant duration of 4. 3 months (in 2007, after an implant approximately 4 months before ), due to unknown reasons. Unk if pt death is device related. No further info regarding this pt was received.
Patient Sequence No: 1, Text Type: D, B5
[21433697]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000002-2008-06001 |
| MDR Report Key | 993100 |
| Report Source | 05,06 |
| Date Received | 2008-02-06 |
| Date of Report | 2007-10-02 |
| Date of Event | 2007-04-04 |
| Date Mfgr Received | 2007-10-02 |
| Date Added to Maude | 2008-02-14 |
| 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 MAILSTOP: PRT46 |
| 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 | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 966057 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-02-06 |