Nouvelle déclaration d'incident
No de la demande: 2016-2756
Numéro de référence du titulaire d'homologation: 2016KP074
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: UNKNOWN
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
Autre
Dog / Chien
Bernese Mountain Dog
1
Homme
8
125
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>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 an unspecified date post application, in 2015, the canine exhibited weight loss, hot spots and intermittent coughing. It was unknown if medical intervention was sought. On an unspecified date in Dec2015, the canine died. No necropsy examination was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss the use of the product on other pet and not to report the death of the canine. No further information is expected. This case is closed.
Mort
Weight loss and intermittent coughing are not expected as signs not in line with product's pharmaco-toxicological profile. Further, location of hot spots unknown but generalized signs are not expected with product use. Scratching/self-trauma and secondary bacterial infection may have contributed to signs. Time to onset is unknown. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause death 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. Moreover, the reason for the initial call was to discuss the use of the product on other pet and not to report the death of the canine. Even though no necropsy was performed, considering the known product profile and exceptionally long time to onset (8 months) for serious sign, sufficient information exists to conclude that the product did not cause the event and product involvement is unlikely.