D
Patient 1
PATIENT WAS UNDERGOING TREATMENT WITH MEDICAL DEVICE. THEY WERE USING PHOTOTHERAPY CHAMBER HANDLES. HANDLE BROKE AND PATIENT FELL, CUTTING THEIR INNER ARM. INJURY REQUIRED 40 STITCHES.
MAUDE MDR 339850
- MDR report key
- 339850
- Report number
- 1045025-2001-00007
- Event key
- 0
- Event type
- 3
- Date of event
- 1994-04-06
- Date received
- 2001-07-03
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- 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 UNIT | ULTRAVIOLET DERMATOLOGICAL LIGHT | ULTRALITE ENTERPRISES, INC. | KGL | V4408 | NA | NA | N | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2001-07-03 | 0 | 1. R |