Nouvelle déclaration d'incident
No de la demande: 2019-3614
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0034345 (Report 576290)
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 collar large dog
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Dog / Chien
Beagle/Boxer (German Boxer) crossbred
1
Homme
12
26.762
kg
Cutanée
>1 mo <= 6 mos / > 1 mois < = 6 mois
Unknown / Inconnu
Système
Unknown / Inconnu
Oui
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On an unspecified date in post application in May 2019, the dog developed generalized alopecia, skin erythema and scrotum swelling. The dog was evaluated by the veterinarian and tumors were found on a rectal examination. On an unspecified date in Jun 2019, the dog was administered an unspecified dose of oxycodone by the animal owner. On 15-Jun-2019 the dog died. It is unknown if a necropsy was performed.
Mort
O - Unclassifiable/unassessable - Skin disorders on other than the application site are not typically seen with topical product administration. Though initial pruritus may be seen with collar use, other skin disorders are not expected. In this case, skin disorders and scrotum swelling are rather associated with the further diagnosed tumor. Scrotum swelling, tumour on rectal examination and death are not expected after product application as inconsistent with pharmaco-toxicological product 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. In this case, diagnosed tumor may be the cause of death. Time to onset is unknown for initially reported signs but it is long for death. Overall, product involvement is considered unassessable.