Nouvelle déclaration d'incident
No de la demande: 2016-7956
Numéro de référence du titulaire d'homologation: 2016KP237
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
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Collar
Autre (préciser)
collarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
Havaneser
1
Femme
0.5
3
lbs
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
Système
>3 days <=1 wk / >3 jours <=1 sem
Oui
Oui
2
Day(s) / Jour(s)
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On 22Jun2016, the dog collapsed and was in lateral recumbency. The dog was administered an unspecified dose of corn syrup orally by the owner and the clinical signs resolved within approximately 2 hours. On 23Jun2016, the dog developed lethargy. On 24Jun2016, the dog was examined by a veterinarian. It is unknown if any treatments were performed. On 25Jun2016, the dog was examined by an emergency veterinarian and diagnosed with dehydration, a hear murmur, and tapeworms. The dog was hospitalized and administered an unknown dose of intravenous fluids. On 27Jun2016, the dog died. No necropsy was performed. The intent of the initial phone call was to discuss use of a different Bayer product and not to report the death of the patient. No further information is expected. This case is closed.
Mort
Reported collapse and lateral recumbency are not expected after topical product application as signs inconsistent with pharmaco-toxicological product profile. Further lethargy is an unspecific sign and may have numerous other causes. Later diagnosed dehydration, heart murmur and tapeworms are not expected either. Further reported 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 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset is long. The owner did not believe in product involvement either as the reason for initial call was to discuss use of a different Bayer product and not to report the death of the patient. Other causes are more likely, e.g. heart disease. Although no necropsy performed, considering the known product profile sufficient information exists to conclude that the product did not cause the event and product involvement is unlikely.