Nouvelle déclaration d'incident
No de la demande: 2019-3138
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0023032 (Report 564578)
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: PENNSYLVANIA
Inconnu
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Large Dog Collar (Flumethrin-Imidacloprid)
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Bulldog X Beagle crossbred
1
Femme
4
Inconnu
Cutanée
Unknown / Inconnu
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 in Apr2019, the dog exhibited behavior change. On 01May2019, the dog was examined by a veterinarian, diagnosed with acute kidney failure and was positive for Lyme disease. On 06May2019 the dog died. It is unknown if a necropsy was preformed. No further information is expected. This case is closed.
Mort
N - Unlikely Reported behavioural sign is unspecific and may have numerous other causes. Signs may occur initially after collar administration but are not expected to appear after long time. In this case, no ticks seen on dog. In case of attachment of ticks these will be killed and fall off the host within 24 to 48 hours after infestation without having had a blood meal, as a rule. However, attachment of single ticks and even sucking of blood and thus transfer of tick borne diseases cannot be excluded while the collar is worn and simply reflects the labeled claim of efficacy that is not 100% against ticks especially when infestation pressure is high. The dog was diagnosed with Lyme disease. Thus, infection with tick borne diseases despite wearing a collar can occur exceptionally and is consistent with the product's claimed efficacy. This issue is addressed in the product information. Further, reported acute renal failure and death are 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. Serious outcome may be associated with diagnosed lyme disease. Time to onset is long. Overall, a product involvement is unlikely.