Nouvelle déclaration d'incident
No de la demande: 2017-7492
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2017-US0068781 (Report 454888)
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: UNKNOWN
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: (Seresto Small Dog)
Autre (préciser)
COLLAROui
Autres unités: Collar
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Chihuahua X Yorkshire Terrier crossbred
1
Femme
7
3.175
kg
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
>1 wk <=1 mo / > 1 sem < = 1 mois
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date post application, in Sep 2017, the canine began loosing weight. On 19 Sep 2017, the canine developed application site irritation. The collar was removed and the application site irritation resolved. On 21 Sep 2017, the collar was reapplied. On 22 Sep 2017, the canine developed application site swelling. On 23 Sep 2017, the canine was lethargic and developed anorexia, vomiting, diarrhea, and hypoglycemia. The dog was taken to a veterinary clinic where blood work was performed and revealed renal failure. The dog died. No necropsy was performed. No further information expected. Case is closed.
Mort
O-Unassessable: Reported weight loss is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Transient mild application site irritation may occur in sensitive animal after product application but the described application site swelling is not typically seen with product use. Scratching/self-trauma may have contributed to sign. Reported digestive disorders are unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Reported lethargy and anorexia are unspecific and may be associated with reported digestive disorders. Hypoglycemia may be consequences of reported anorexia. Reported renal failure and death are not expected following appropriate topical product application as inconsistent with products 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. However, renal failure which was revealed by blood work may have contributed to the serious sign (death). Though time to onset is consistent for application site disorders, it is long for other reported signs. Other causes must be considered. No necropsy was performed. Considering known product safety profile and unexpected serious outcome, a product relation is unassessable.