inforMED
DeathLEJ

PURETAN

Received Feb 21, 2002 · Event occurred May 31, 2001

Report 1641486-2002-00001 · MDR key 380529

Device

Generic name

Uv Sunlamp Product

Model number

ASTRAL ULTRA

Catalog number

NA

Lot number

NA

Product problems

  • Unknown (for use when the device problem is not known)

Patient

21 YR

  • Death
  • Fall
  • Therapy/non-surgical treatment, additional

Narrative

Description of Event or Problem

MFR INFORMED ON 2/2002 OF A DEATH IN A TANNING FACILITY. AN ATTENDANT FOUND THE DECEASED, LYING ON THE FLOOR, AND THE TYLER POLICE DEPT. WAS IMMEDIATELY SUMMONED TO THE SCENE. ACCORDING TO THE SALON OWNER, A POLICE INVESTIGATION AND AUTOPSY WERE PERFORMED. THE POLICE INVESTIGATION HAS BEEN CLOSED, AND THE AUTOPSY WAS NOT ABLE TO DETERMINE CAUSE OF DEATH. THERE IS NO EVIDENCE AS TO WHETHER OR NOT THE DECEASED HAD USED THE TANNING DEVICE. FACILITY HAS RELEASED THE DEVICE FOR SERIVCE. MFR HAS MADE SEVERAL ATTEMPTS TO CONTACT SALON OWENR FOR PERMISSION TO INSPECT THE DEVICE IN THEIR PRESENCE, AND HAS RECEIVED NO RESPONSE.