Nouvelle déclaration d'incident
No de la demande: 2015-3846
Numéro de référence du titulaire d'homologation: 2015KP200
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 2920 Matheson Boulevard
Ville: Missisaugua
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 - Large Dog
Autre (préciser)
CollarOui
Autres unités: collar
Site: Animal / Usage sur un animal domestique
Autre
Dog / Chien
Cairn terrier
1
Homme
13
18.5
lbs
Cutanée
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
Système
>1 wk <=1 mo / > 1 sem < = 1 mois
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 23Aug2014, the canine began coughing and developed dyspnea. On 25Aug2014, he was examined by a veterinarian and no known diagnostics or treatments were performed. On 26Aug2014, all signs worsened and the canine died. No known necropsy examination was performed.Due to the sensitive nature of the communication, specific event details were not obtained, nor will such be sought. The reason for the initial call was to discuss flea control on another canine in the household and not to report the death of this patient. No further information is expected. This case is closed. Follow-up received on 2014-09-18 In approximately Jun2014, a 13 year old, 18.5 pound, male, Cairn Terrier canine of unknown reproductive status, was administered an unknown dose of a topical fipronil product. On approximately 28Jul2014, the canine, in unknown condition with fleas and a history of loose bowel movements, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar around his neck by the owner. On approximately 23Aug2014, the canine began coughing and developed dyspnea. On 25Aug2014, he was examined by a veterinarian and no known diagnostics or treatments were performed. On 26Aug2014, all signs worsened and the canine died. No known necropsy examination was performed. Due to the sensitive nature of the communication, specific event details were not obtained, nor will such be sought. The reason for the initial call was to discuss flea control on another canine in the household and not to report the death of this patient. Follow-up received on 28th Oct 2014: No further information is expected. This case is closed.
Mort
N - Unlikely. Respiratory signs (such as coughing and dyspnea) are unspecific signs and may have many other possible causes. Time to onset too long (28 days) to explain product involvement. The dog was examined by a veterinarian however no known diagnostics or treatments were performed. Death is not expected following appropriate topical product application as inconsistent with products pharmaco-toxicological profile. 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. No known necropsy examination was performed to determine the specific cause of death. The reason for the initial call was to discuss flea control on another canine in the household and not to report the death of this patient. The dog was geriatric patient and had a history of loose bowel movements and fleas. Thus, other unrelated causes were considered responsible for signs and outcome. Considering the provided data, sufficient information exists to confirm that the product did not cause the event and product involvement was considered unlikely