Nouvelle déclaration d'incident
No de la demande: 2018-6432
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2018-US0064062 (Report 530534)
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: GEORGIA
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Large Dog
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Crossbred (Retriever - Labrador x)
1
Homme
10
27.216
kg
Cutanée
>3 days <=1 wk / >3 jours <=1 sem
>24 hrs <=3 days / >24 h <=3 jours
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 17-Oct-2018, the dog exhibited diarrhea and intermittent vomiting. On approximately 19-Oct-2018, the owner removed the Seresto collar and bathed the dog in dish liquid. On approximately 20-Oct-2018, the dog recovered without medical intervention. No further information is expected. This case is closed. Follow up received on 23rd Oct 2018: 20-Oct-2018, the dog recovered without medical intervention. On 25 Oct 2018, the dog died. A necropsy is pending. Follow up received on 26th Oct 2018: On approximately 20-Oct-2018, the vomiting and diarrhea resolved, but the dog was weak. On 24 Oct 2018, the dog developed diarrhea. On 25 Oct 2018, the dog died.
Mort
O - Unclassifiable/unassessable Reported diarrhoea and vomiting are unspecific signs and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility) however mild gastrointestinal signs may occur shortly after product application. Time to onset is rather long. Weakness is unspecific as well. In this case it may be consequence of gastrointestinal signs. 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. However no oral product exposure reported in this case. 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Other unrelated causes must be considered in this geriatric animal. Time to onset is long. Considering low level of information (animal health status, medical history and necropsy report are unknown), a product relation is unassessable