SUE FORM C: TRANSMISSION BY A COMPETENT AUTHORITY OF SUE REPORTED BY HEALTH PROFESSIONALS OR END USERS TO OTHER COMPETENT AUTHORITIES AND

RESPONSIBLE PERSON
(according to Article 23 of Regulation (EC) No 1223/2009 on cosmetic products) 9) Relevant underl !n" #$nd!t!$n% &) Ca%e re/$rt 0) C$(/etent Aut+$r!t Yes No n!no"n If yes, specify # C$(/etent Aut+$r!t Ca%e Ident!)!#at!$n Nu(-er# /em.er *tate# Rele$ant treatment(s)# 2(pe of t%e report# Competent Aut%orit( name# Additional concurrent use of ot%er5inal products (drugs& food supplements& ''')# ,nitial 5ollo"6up
+ate recei$ed .( Competent Aut%orit(# dd/mm/(((( *ending date to responsi.le person and ot%er Competent Allergic diseases& specif(# If tests previously performed, specify the type and results # Aut%orities# dd/mm/((((

&') Relevant (ed!#al !n)$r(at!$n * +!%t$r

Address and local contact details#

1) Ser!$u%ne%% #r!ter!a Cutaneous diseases& specif(# Te(/$rar $r /er(anent )un#t!$nal !n#a/a#!t )t%er rele$ant underl(ing disease(s)# D!%a-!l!t *!in specificities including p%otot(pe#
H$%/!tal!2at!$n

)t%ers (re/$rter example: specific climatic conditions or specific exposure): 3) Pr!(ar 4) End u%er &&) Ca%e (ana"e(ent
7ealt% professional +rug prescription# Name of product (,NN) )t%er (specify)# 7as t%e reported information .een confirmed .( a medical professional# Ye No

C$n"en!tal an$(al!e% I((ed!ate v!tal r!%5 Deat+

a) Treat(ent,%) $) t+e SUE

Consumer

Code#

Age (at time of * E)# +ose 5emale Countr( of residence# *e-#

+ate of .irt%# (((( +uration /ale n!no"n

6) Su%/e#ted /r$du#t -) Ot+er (ea%ure,%): a) Full na(e $) %u%/e#ted /r$du#t +uration / complementar( details# #) Ser!$u%ne%% Compan(# $) unde%!ra-le e))e#t

7) De%#r!/t!$n $) %er!$u% unde%!ra-le e))e#t ,SUE) a) T /e $) e))e#t

.Countr( of occurrence# 6+ate of onset# dd/mm/(((( 62ime from t%e .eginning of use to onset of first s(mptoms# (minutes/ %ours/da(s/mont%s) 62ime from last use to onset of first s(mptoms# (minutes/ %ours/da(s/mont%s)

888888888888888888888888888

#.&) Fun#t!$nal !n#a/a#!t (if applicable) Categor( of 8roduct# +escription#

9atc% num.er# Notification num.er#

,f temporar(& specif( t%e duration# E-pert e$aluation a$aila.le -) U%e $) /r$du#t Correcti$e treatment of t%e functional incapacit(#
+ate of first e$er use# dd/mm/(((( 5re:uenc( of use#(if times per (da(/"ee!/mont%/(ear) #.0) D!%a-!l!t applicable) & specif( t%e 0#

-Reported signs/ s(mptoms#

/edical certificate a$aila.le

+escription# 8rofessional use#

Yes

No

.Reported diagnosis (if an()#

Application site(s)# 8roduct use stopped #

E-pert e$aluation a$aila.le

N/A

/edical certificate a$aila.le -) L$#at!$n $) t+e SUE

*!in& area(s) concerned # *calp 7air E(es 2eet% Nails ;ips /ucosae& specif(# +ose +uration )t%ers& specif(# * E in area of product application * E out of area of product application

#.1) H$%/!tal!2at!$n (if applicable): Yes No n!no"n +uration of %ospitali1ation# +ate of stopping t%e product use# dd/mm/((((

Correcti$e treatment recei$ed during t%e %ospitali1ation# #) Re.e9/$%ure t$+rug t+e %u%/e#ted prescription# /r$du#t Name of product (,NN)
n!no"n Not performed d) Ot+er %u%/e#ted #$%(et!# u%ed #$n#$(!tantl : 2reatment /measure ta!en after/r$du#t% %ospitali1ation# 888888888888888888888888888 888888888888888888888888888: #.3) C$n"en!tal an$(al!e% (if applicable) # 8ositi$e Negati$e
Complementary information can be attached to the document /related in the narrative +etected during pregnanc(

;) +etected Out#$(eafter $) SUE,%) deli$er(

Reco$ered

E-pert e$aluation a$aila.le

#.4) I((ed!ate v!tal r!%5 (if applicable): ,mpro$ingand specific Aftereffects (se:ualae) 2reatment measures#
)t%er#

If recovered, specify the time for recovering: )ngoing

3ersion# 11 4ul( 2013

n!no"n

#.6) Deat+ (if applicable): +ate# dd/mm/(((( +iagnosis# &0) C$(/le(entar !nve%t!"at!$n% Yes
No If yes , specify #

/edical certificate a$aila.le

Aller"!# te%t!n" : *!in test(s) performed "it% t%e suspected cosmetic product(s) #
8roduct(s) tested /et%od(s) used Readings on Results

*!in test(s) performed "it% t%e su.stances ( if available, attach the complete results to this form) )t%er results of allergic testing# <<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<'' )t%er additional in$estigation(s) (specify, including results):

&1 ) C$(/etent Aut+$r!t %u((ar a) Narrat!ve

-) F$ll$<.u/

#) Re%/$n%!-le Per%$n #au%al!t a%%e%%(ent: 3er( li!el( ;i!el( Not clearl( attri.uta.le nli!el( E-cluded nassessa.le

d) C$(/etent Aut+$r!t #au%al!t a%%e%%(ent 3er( li!el( ;i!el( Not clearl( attri.uta.le nli!el( E-cluded nassessa.le

e) Mana"e(ent 7as t%is case alread( .een sent .( t%e Responsi.le 8erson=# *ending date# Yes No n!no"n

)) C$rre#t!ve a#t!$n% Yes

No If yes , specify #

") C$((ent% ,/lea%e %tate nu(-er $) atta#+(ent%= !) an ):

3ersion# 11 4ul( 2013

3ersion# 11 4ul( 2013