Nouvelle déclaration d'incident
No de la demande: 2011-3832
Numéro de référence du titulaire d'homologation: 822484
Nom du titulaire (nom légal complet, aucune abbréviation): S.C. Johnson and Son, Limited
Adresse: 1 Webster Street
Ville: Brantford
État: ON
Pays: Canada
Code postal /Zip: N3T 5R1
Incident chez l'humain
Pays: CANADA
État: ONTARIO
ARLA No d'homologation 29313 ARLA No de la demande d'homologation EPA No d'homologation.
Nom du produit: OFF! familycare eucalyptus lotion Insect Repellent 118mL- Canada
Oui
Inconnu
Site: Personal use / Usage personnel
Autre
Sexe: Femme
Âge: >1 <=6 yrs / > 1 < = 6 ans
Système
>8 hrs <=24 hrs / > 8 h < = 24 h
Oui
Non
Non professionnel
Application
Aucun
Peau
<=15 min / <=15 min
>2 hrs <=8 hrs / > 2 h < = 8 h
7/19/2011 Caller reports that she applied the product all over her (age) yr old daughter's body on 7/17/2011, for the first time at 3 pm. She then bathed her at 6 pm and the child developed swelling involving her face starting at 7 pm. The swelling was worse an hour later and she took her to ER around 8 pm. The ER physician diagnosed her daughter with an atypical allergic reaction and gave her Benadryl. By morning the swelling was gone. Caller states she applied to other areas of body and had swelling only developed on her face. The child has an allergy to milk. No hives or rash were reported.
Modérée
The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and can not form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. The differential diagnosis for a skin or allergic condition of this nature would include multiple potential etiologies which, in addition to this product, include such factors as plant allergens, mold, food, infectious pathogens, medications, dietary supplements, etc.. Target allergy testing would be required before labeling this product as the causative agent. Also, it would be unusual for the allergic reaction to manifest in the form of swelling only on the face whereas other areas of the body where the product was applied show no adverse reaction.