Nouvelle déclaration d'incident
No de la demande: 2013-3250
Numéro de référence du titulaire d'homologation: 2013AM155
Nom du titulaire (nom légal complet, aucune abbréviation): Bayer Inc
Adresse: 77 Belfield Rd
Ville: Toronto
État: ON
Pays: Canada
Code postal /Zip: M9W 1G6
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 152
Nom du produit: Advantage II large cat
Liquide
Oui
Unités: mL
Site: Animal / Usage sur un animal domestique
Propriétaire de l'animal
Cat / Chat
domestic shorthair
1
Inconnu
2.5
13
lbs
Cutanée
Unknown / Inconnu
>24 hrs <=3 days / >24 h <=3 jours
Système
Unknown / Inconnu
Oui
Inconnu
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
Advantage Multi 18 was applied to a 2.5 year old, 13 pound Domestic Shorthair on 4Oct11. This was not the first time application of the product. The cat presented at the veterinary clinic on 7Oct11 for urinating all over the house and acting very hyperactive and "strange." On approximately 9Oct11, the owner found the cat deceased. It should be noted that the cat did have access to the outdoors. A necropsy is pending. 20 Oct 2011: Receipt of technical assessment "The complained batch was manufactured and released according to specification. No deviations occured which lead to the complained AE. " Follow-up, 24Oct11 - The clinic reports they have a low suspcion that the clinical signs were product related. The necropsy results are listed below: General results: Kidney - Fatty vacuolation of the majority of cortical tubules is present. Acute tubular degeneration is observed in some clusters of tubules, characterized by increased eosinophilia, and hyalinity, with cytoplasm taking on a granular appearance and loss of nuclear detail. Tubular lumina occasionally contain proteinaceous casts. Lung - Vascular congestion and edema are pronounced. A large pulmonary artery is occluded by an organized thrombus. Liver - Extensive expanses of hepatic parenchyma exhibit acute hepatocellular necrosis, with preservation of cellular outline, but loss of nuclear and cytoplasmic detail. Histologic diagnosis: Acute tubular nephrosis. Fatty degeneration, kidney. Pulmonary thrombosis. Hepatic infarction. Follow-up, 8 Nov 2011: Further information revealed the involved product was actually Advantage II Large Cat, and not Advocate as originally reported.
Mort
Signs and particularly fatal outcome not anticipated with appropriate topical product administration as inconsistent also with Advocate's pharmaco-toxicological profile. Onset time of 3 days not suggestive of product involvement either. Product used before on cat without causing any signs. Sudden death probably not product related but caused by other underlying health problems or intoxication, as cat had access to outside. Technical evaluation not indicative of product involvement. Necropsy results suggested other etiology for death (acute tubular nephrosis, pulmonary thrombosis, heaptic infarction, acute fatty degeneration of kidney). Thus, relation to Advocate which was finally reported as used product unlikely.