MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-01-19 for EDWARDS PERICARDIAL PATCH 4700 NA manufactured by Edwards Lifesciences.
[21255151]
A nurse accidently splashed glutaraldehyde onto her face as she was sealing the jar.
Patient Sequence No: 1, Text Type: D, B5
[21319962]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000002-2007-00041 |
| MDR Report Key | 807864 |
| Report Source | 05,06 |
| Date Received | 2007-01-19 |
| Date of Report | 2006-12-19 |
| Date of Event | 2006-12-19 |
| Date Facility Aware | 2006-12-19 |
| Date Mfgr Received | 2006-12-19 |
| Date Added to Maude | 2007-01-25 |
| 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 | ALLISON MEZZANATTO |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492502562 |
| 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 | EDWARDS PERICARDIAL PATCH |
| Generic Name | PERICARDIAL PATCH |
| Product Code | MFX |
| Date Received | 2007-01-19 |
| Model Number | 4700 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 795351 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US |
| Baseline Brand Name | EDWARDS PERICARDIAL PATCH |
| Baseline Generic Name | NA |
| Baseline Model No | 4700 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | PERICARDIAL PATCH |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 48 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K833763 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-01-19 |