Document 8VQDB606MXgDr5OveYn77qkDB

F O 1 14-6210 C A ER S R eports A llegedly Related to C ancer in M ultiple C osm etics S earch T erm s: P ro d u cts Listed F D A 's C e n te r fo r F ood S a fety and A p p lie d N u trition 's (C F S A N 's) A d ve rse E vent R e porting S ystem (C A E R S ) is a post-m a rke t su rveillan ce system th a t c o lle cts rep o rts abo ut adve rse even ts and product com p la in ts that are a llege dly related to C F S A N -regu lated products. T he se pro d u cts in clude conve ntional fo o d s (and beve rag es), die ta ry supp lem ents, infant form u la s and cosm etics. T h e a d v e rs e e ve n t re p o rts a b o u t a p ro d u c t an d th e to ta l n u m b e r o f a d v e rs e e v e n t re p o rts fo r th a t p ro d u c t in C A E R S on ly re fle c t in fo rm a tio n A S R E P O R T E D a n d do n o t re p re s e n t any co n c lu s io n by F D A a b o u t w h e th e r th e p ro d u c t a c tu a lly cau se d the adve rse e ve n ts. T h e a tta ch e d re p o rts are w h a t have been e n te re d in to C A E R S d u rin g th e re q u e s te d d a te s (the search date u sed w a s th e C A E R S e n te re d date, a s o p p o se d to o th e r d a te s such a s th e F D A R e ce ive d D ate o r C A E R S Receivec D ate, etc.). T h e re p o rts su b m itte d to F D A v a ry in th e q u a lity a nd re lia b ility o f th e in fo rm a tio n p ro v id e d . S o m e re p o rts to F D A do n o t n e c e s s a rily in c lu d e all re le v a n t d a ta , such a s w h e th e r an in d iv id u a l a ls o su ffe re d fro m o th e r m e d ic a l c o n d itio n s o r u se d o th e r p ro d u c ts o r m e d ic a tio n s a t th e s a m e tim e . R e p o rts m a y n o t in c lu d e a c c u ra te o r c o m p le te c o n ta c t in fo rm a tio n f o r F D A to s e e k fu rth e r in fo rm a tio n a b o u t th e e v e n t, o r c o m p la in a n ts m a y c h o o s e n o t to p a rtic ip a te in a fo llo w -u p in v e s tig a tio n . W h e n im p o rta n t in fo rm a tio n is m is s in g fro m a re p o rt, it is d iffic u lt fo r F D A to fu lly e v a lu a te w h e th e r th e p ro d u c t c a u s e d th e a d v e rs e e v e n t o r sim p ly c o in c id e d w ith it. T h e re a ls o m a y be d u p lic a te re p o rts in C A E R S fo r th e s a m e a d v e rs e e ve n t b e ca u se m ultiple peo ple (such as an injured c o n su m e r and a health care pro vid e r w h o trea ted him o r her) m ay have s ubm itted reports. B e cause C A E R S is constantly upd ated w ith n e w in form ation, the num b e r o f rep o rts fo r a given product and the con te n t o f in dividual reports m ay cha n g e o v e r tim e. Report # RA_CAERS Created Date B ra n d /P ro d u c t Name PRI_FDA Industry Code PI_One Row Ingredients S ym ptom s Outcom es 83239 0 1 /2 0 /2 0 0 6 84265 0 3 /0 9 /2 0 0 6 84269 0 3 /0 9 /2 0 0 6 144084 1 0 /0 3 /2 0 1 1 155918 0 8 /2 9 /2 0 1 2 162802 0 2 /2 8 /2 0 1 3 0 2 /2 8 /2 0 1 3 OPI NAIL POLISH ESTEE LAUDER DOUBLE M ATTING, PEBBLE COLOR ESTEE LAUDER DOUBLE M ATTING, PEBBLE COLOR COPPOLA B R A Z IL IA N K E R A T IN L U B R ID E R M D A IL Y M O IS T U R E LOTION FOR NORMAL TO DRY LOTION 53 53 53 53 53 ACTIVE SERUM 53 HAIR COM PLEX 53 UNKNOWN UNKNOWN UNKNOWN FORMALDEHYDE MISSING LABEL UNKNOWN UNKNOWN BREAST CANCER PAIN, SCAR, SKIN C ANCER, HYPERPLASIA, DYSPLASIA, RASH PAPULAR, SKIN CANCER, INFECTION, LYM PHADENECTO M Y, M YELOID M ETAPLASIA, M YELO ID M ETAPLASIA, DEPRESSED LEVEL OF CONSCIOUSNESS SKIN CANCER, DYSPLASIA, SKIN GRAFT, HYPERPLASIA, ACNE LYM PHADENO PATHY, HYPO TRICHOSIS, THYROID CANCER, M EM O RY IM PAIRM ENT, ABO RTION SPO NTANEO US, FATIG UE BLADDER CANCER NON-SERIOUS INJURIES/ ILLNESS VISITED A HEALTH CARE PROVIDER, DISABILITY DISABILITY, V ISITED A HEALTH CARE PROVIDER VISITED A HEALTH CARE P R O V ID E R OTHER SERIOUS (IM PO RTANT M EDICAL EVENTS) HYPO TRICHO SIS, SKIN CANCER OTHER SERIO US (IM PO RTANT M ED IC AL EVENTS), LIFE T H R E A T E N IN G Page 1 Report # RA_CAERS Created Date B ra n d /P ro d u c t Name P R I_ F D A Industry Code 165492 05/14/2013 170684 10/01/2013 172659 12/19/2013 9 L U B R ID E R M U N S P E C IF IE D (DERM ATOLOGI CAL PRODUCTS) LO T IO N C O C O 'S EXTRA STRENGTH B R A Z IL IA N M YSTIC TAN SPRAY ON TAN DARK COLOR 53 53 53 PI_One Row Ingredients Sym ptoms UNKNOWN UNKNOWN D IHYDRO XYACTO NE OVARIAN CANCER BREAST CANCER LUNG NEO PLASM M ALIG NANT, BRAIN CANCER M ETASTATIC, BRO NCHIO LO ALVEO LAR CARCINOM A, HEPATIC NEO PLASM M ALIG NANT O utcom es OTHER SERIO US (IM PO RTANT M EDICAL EVENTS) OTHER SERIO US (IM PO RTANT MEDICAL EVENTS) DEATH, VISITED A HEALTH CARE PROVIDER, HOSPITALIZATION Page 2