D
Patient 1
THE SOLUTION WAS FOUND LEAKING WITHIN THE PACKAGING PRIOR TO USE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?UNKNOWN.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
MAUDE MDR 3273391
- MDR report key
- 3273391
- Report number
- 3273391
- Event key
- 0
- Event type
- 3
- Date of event
- 2013-05-23
- Date received
- 2013-08-01
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- U
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EXIDINE | SKIN PREP TRAY | CAREFUSION | OJU | * | 4489 | 0000536006 | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-08-01 | 0 | |
| 2 | 2013-08-01 | 0 |