D
Patient 1
LIGHT BULBS MALFUNCTIONED. PT GOING TO HOSP AS A PRECAUTION REGARDING BULB MALFUNCTION BUT NO PT INJURY. PT RECEIVED PAIN MEDS AND HAD ALREADY RESUMED TREATMENTS ON A DIFFERENT UNIT.
MAUDE MDR 643112
- MDR report key
- 643112
- Report number
- 1045025-2005-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2005-08-17
- Date received
- 2005-10-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 999
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- WILLIAM MCMILLAN
- 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 FULL BODY PHOTOTHERAPY UN | ULTRALITE DERMATOLOGICAL LIGHT | ULTRALITE ENTERPRISES, INC | KGL | V4848NB | NA | NA | N | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2005-10-26 | 0 | 1. H |