Nouvelle déclaration d'incident
No de la demande: 2021-0147
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2020-US0059951 (Report 678180)
Nom du titulaire (nom légal complet, aucune abbréviation): Elanco
Adresse: 150 Research Lane, Suite 120
Ville: Guelph
État: ON
Pays: Canada
Code postal /Zip: N1G4T2
Incident chez l'humain
Pays: UNITED STATES
État: TENNESSEE
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar unknown
Autre (préciser)
COLLARInconnu
Inconnu
Autre
Sexe: Homme
Âge: Unknown / Inconnu
Système
>1 wk <=1 mo / > 1 sem < = 1 mois
Oui
Oui
11
Day(s) / Jour(s)
Non professionnel
Application
Inconnu
Peau
Unknown / Inconnu
>30 min <=2 hrs / >30 min <=2 h
On approximately 01-Sep-2019, a man, with no known concomitant medical conditions, was exposed to a Seresto Small Dog (Flumethrin-Imidacloprid) collar when he placed the collar around the neck of a dog in the home. Approximately 2 hours post exposure, the man experienced anaphylaxis, shaking, and convulsions. The man was evaluated by a physician in the emergency room, administered an unspecified medication, and placed in a coma. On approximately 08-Sep-2019, the man recovered. On approximately 14-Sep-2019, the man was exposed to a Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar when he placed the collar around the neck of another dog in the home. Approximately 2 hours post exposure, the man experienced anaphylaxis, jerking, shaking, and convulsions. The man was evaluated by a physician in the emergency room, administered an unspecified medication, and placed in a coma. On approximately 18-Sep-2019, the man recovered.
Majeure
B - Possible Individual was exposed to unknown amount of collar while applying the collar. Affected site is not in line with exposed site. No information about indirect exposure of affected site via contaminated hands. Reported serious sign such as convulsion is not expected with appropriate product use as not consistent with product¿¿¿¿¿¿s pharmacological profile. Shaking is not expected sign and, in this case likely associated with convulsion. Hypersensitivity reactions such as anaphylaxis to the collar are not typically seen and not consistent with product¿¿¿¿¿¿s pharmacological profile as well. None of the active ingredients is known to have immuno-toxicological effects nor causing dermal sensitization. However, hypersensitivity may exceptionally occur with direct product exposure to every product combined with respective disposition in the individual. Signs resolved and then reoccurred after subsequent exposure to collar. Product information states that user should wash their hands with cold water after fitting of collar. It is unknown whether this was followed or not. Time to onset is short. Considering short time to onset and reappear of reactions after product exposure, product involvement cannot be ruled out. Thus, product involvement is assessed as possible.