D
Patient 1
ACCORDING TO THE REPORTER: DEVICE WAS BROKEN.
MAUDE MDR 4902278
- MDR report key
- 4902278
- Report number
- 9610849-2015-00001
- Event key
- 0
- Event type
- 3
- Date received
- 2015-07-09
- 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#
- Contact
- SHARON MURPHY
- Address
- 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US
- Phone
- 203-203-2034
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VITAL VUE* LIGHT POWER SOURCE (110V) | SINGLE USE LAPAROSCOPIC HAND INSTRUMENTS | COVIDIEN, FORMERLY NELLCOR PURITAN BENNE | HBI | 8886828401 | 8886828401 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-07-09 | 0 |
Event Narratives#
N
Patient 1
(B)(4).