D
Patient 1
3 PTS RECEIVED 2ND DEGREE BURNS WHILE RECEVING TREATMENT WITH THE DEVICE.
MAUDE MDR 335822
- MDR report key
- 335822
- Report number
- 1045025-2001-00002
- Event key
- 0
- Event type
- 3
- Date received
- 2001-06-01
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Address
- 390 FARMER COURT LAWRENCEVILLE GA 30045 US
- Phone
- 770-770-7709
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ULTRALITE 6809 FULL BODY PHOTOTHERAPY UNIT | ULTRALITE DERMATOLOGICAL LIGHT | ULTRALITE ENTERPRISES, INC. | LBI | V4412AB | NA | UNK | N | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2001-06-01 | 0 | 1. O |