LIGHT SOURCE

Additional Manufacturer Narrative

IN BRIEF A HEADLAMP WAS USED TO TRANSILLUMINATE AN INFANTS HAND AND THIS LEAD TO BILATERAL PALM BLISTERS ON THE INFANT. MEDICAL CTR USES A LARGE NUMBER OF LUXTEX PRODUCTS SO IT WAS ASSUMED BY THE USER THAT A LUXTEC HEADLAMP WAS USED. WE CONTACTED CAREN SPAGNUOLO AT MED CTR TO GAIN ADDITIONAL DETAILS ON WHICH LUXTEC PRODUCT WAS USED AND CAREN LET US KNOW THAT SHE WAS NOT SURE WHICH PRODUCT WAS USED. IF A LUXTEC HEADLAMP WAS USED IT WAS USED OUTSIDE ITS INDICATIONS FOR USE. NO LUXTEC PRODUCTS ARE INDICATED FOR USE FOR TRANSILLUMINATION.