Nouvelle déclaration d'incident
No de la demande: 2012-5105
Numéro de référence du titulaire d'homologation: 1006834
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: MANITOBA
ARLA No d'homologation 30211 ARLA No de la demande d'homologation EPA No d'homologation.
Nom du produit: OFF! Clip-On Mosquito Repellent 46mg - Canada
Oui
Inconnu
Site: Personal use / Usage personnel
Personne affectée
Sexe: Femme
Âge: >19 <=64 yrs / >19 <=64 ans
Système
>8 hrs <=24 hrs / > 8 h < = 24 h
Oui
Non
Non professionnel
Application
Aucun
Respiratoire
<=15 min / <=15 min
>2 hrs <=8 hrs / > 2 h < = 8 h
July 13, 2012 Caller used the product in the evening on 6/29/12 while camping. Caller estimates that she used the product for 5 min total, 2-3 min then turned the product off then used for another 2-3 min. The caller woke up at approx 4am (6-8 hours after use) due to extreme itching on the palms of her hands and soles of her feet. Caller states that shortly after she woke up she was extremely tired and went back to sleep for a short period of time. When she woke back up she felt nauseous and had some diarrhea. The caller tried to walk to the car but found that she was unable to move her legs. The caller was carried to the car and taken to an emergency room. Several tests were done including EKG monitoring, unspecified bloodwork and CT scan. All tests came back normal. The caller was observed for a few hours in the ER and treated with an unspecified medication. Caller states that the intense itching resolved approx 1 hour after arriving at the hospital. Caller states that she was asx within 24 hours of initial exposure.
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 reported signs and symptoms are not consistent with the known toxicological profile of the active ingredient used in this product. Several potential etiologies must be considered when developing a differential diagnosis for this patient's ailment. When considering the body of regulatory data and post-marketing data as well as the weight of scientific peer reviewed evidence on the active ingredient used in this product a definitive causal relationship cannot be established.