D
Patient 1
A NURSE ACCIDENTLY SPLASHED GLUTARALDEHYDE ONTO HER FACE AS SHE WAS SEALING THE JAR.
MAUDE MDR 807864
- MDR report key
- 807864
- Report number
- 6000002-2007-00041
- Event key
- 0
- Event type
- 3
- Date of event
- 2006-12-19
- Date received
- 2007-01-19
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 2
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Related Records
Manufacturer Contact
- Contact
- ALLISON MEZZANATTO
- Address
- ONE EDWARDS WAY IRVINE CA 92614 US
- Phone
- 949-949-9492
- Report source
- M
- Manufacturer link flag
- Y
Devices
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EDWARDS PERICARDIAL PATCH | PERICARDIAL PATCH | EDWARDS LIFESCIENCES | MFX | 4700 | NA | NA | K833763 | N | R | N |
Patients
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-01-19 | 0 | 1. R |
Event Narratives
N
Patient 1
DEVICE NOT RETURNED.
Related GUDID Devices By Product Code
No records found.