Nouvelle déclaration d'incident
No de la demande: 2019-5927
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0054813 (Report 597051)
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer inc
Adresse: 2920 Matheson Blvd
Ville: Mississaugua
État: ON
Pays: Canada
Code postal /Zip: L4W 5R6
Incident chez un animal domestique
Pays: UNITED STATES
État: WASHINGTON
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar Large
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Shih Tzu
1
Inconnu
15
Inconnu
Cutanée
>1 mo <= 6 mos / > 1 mois < = 6 mois
Unknown / Inconnu
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date post application, in approximately 2019, the dog exhibited weight loss, anemia, weakness and was unable to stand, with visible fleas. The dog was not examined by a veterinarian and the clinical signs and fleas continued. Follow up received on 18th Sept 2019: On approximately 14 Sep 2019, the dog died. Necropsy was not performed. No more information is possible. The case is closed.
Mort
O - Unclassifiable/unassessable Reported anemia and weight loss are not expected with appropriate topical product application. These signs are not consistent with pharmaco-toxicological product profile. Unable to stand is not typically seen with appropriate topical product administration. Further reported lethargy is unspecific and may have various other causes. Time to onset is unknown. Presence of fleas is not a sign of inefficacy. Product is not a repellent. Fleas have to be on the animal to come into contact with the product to be killed. Unknown if re-infestation from infested environment (e.g. by means of other untreated animals, wildlife) occurred. In this case, product was applied previously, however exact treatment date and duration of treatment are unknown. Furthermore 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, particularly during the first week after application and also thereafter. Outcome may be consequence of underlying causes in this geriatric animal. Time to onset is long for death. Overall, Product relation is considered unassessable.