Nouvelle déclaration d'incident
No de la demande: 2018-2730
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0032308 (Report 498290)
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc
Adresse: 2920 Matheson BLVD
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L5W5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: LOUISIANA
Inconnu
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)
COLLAROui
Autres unités: Collar
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Boston Terrier
1
Femme
15
Inconnu
Cutanée
Unknown / Inconnu
Unknown / Inconnu
Système
Persisted until death
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unknown date post collar administration in Dec2017, the canine exhibited dementia. On an unknown date in Jan2018, the canine died. It is unknown if the canine was euthanized or if a necropsy was performed. No further information is expected. This case is closed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss a flea issue with the other canine in the household and was not to report the death of the patient.
Mort
N - Unlikely Dementia is neither expected nor inline with products pharamaco-toxicological profile. Death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin when wearing the collar. Animal involved in this case was geriatric and dementia is not uncommon in elderly pets, hence other etiologies are known for this event. Further, the reason for the initial call was to discuss a flea issue with the other canine in the household and was not to report the death of the patient. Finally, sufficient information exists to rule out product relation. Overall, a product relation consider is considered to be unlikely.