OtherFTC
ULTRALITE PHOTO THERAPY UNIT
Received May 10, 2002 · Event occurred Dec 1, 2001
Report 1045025-2002-00002 · MDR key 393712
Device
Generic name
Uv Dermatology Light
Manufacturer
Ultralite Enterprises IncModel number
V4408Catalog number
V4408
Lot number
NA
Product problems
- Unknown (for use when the device problem is not known)
Patient
UNKNOWN
- Burn(s)
Narrative
Description of Event or Problem
CUSTOMER CALLED UEI (05/08/2002) FOR CALIBRATION SERVICE OF THEIR UNIT. DURING THE DISCUSSION OF SCHEDULING, REPORTER INFORMED UEI OF A PT (UNKNOWN) WHO WAS BURNED SEVERELY IN DEC. REPORTER HAD LITTLE DETAIL ON THE EVENT. REPROTER DID SAY THAT THE PT WAS SUING THE USER FACILITY. REPORTER INFORMED THE COMPANY THAT THE UNIT HAS CONTINUED TO BE USED SINCE DECEMBER.