Nouvelle déclaration d'incident
No de la demande: 2019-7170
Numéro de référence du titulaire d'homologation: USA-BAYERBAH-2019-US0069590 (Report 612286)
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: VIRGINIA
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-155
Nom du produit: Seresto Small Dog collar
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-141
Nom du produit: K9advantix II small dog
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. 11556-142
Nom du produit: K9advantix II medium dog
ARLA No d'homologation ARLA No de la demande d'homologation EPA No d'homologation. Inconnu
Nom du produit: Advantage Treatment Shampoo for dogs and puppies
Liquide
Autre (préciser)
COLLAROui
Autres unités: COLLAR
Site: Animal / Usage sur un animal domestique
Inconnu
Propriétaire de l'animal
Dog / Chien
Spitz - German Pomeranian/Chihuahua crossbred
1
Homme
3
4.99
kg
Cutanée
>1 wk <=1 mo / > 1 sem < = 1 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
Système
Unknown / Inconnu
Non
Non
Mort
Treatment / Traitement
(p.ex. description des symptômes tels que la fréquence et la gravité
On approximately 01-Sep-2019, the collar was removed. On 18-Oct-2019, the dog exhibited weight loss to approximately 10 pounds On 07-Nov-2019, the dog exhibited lethargy and difficulty walking. Approximately 8 hours post onset, the dog died. The dog was not evaluated by a veterinarian, and no necropsy was performed. No further information is expected. This case is closed. Updated information 27-Nov-2019: Correction of product: Dog was bathed with MGK Advantage Treatment Shampoo for Dogs and Puppies (unspecified) every 2 weeks since Mar-2019.
Mort
Seresto Small Dog collar: Reported weight loss, lethargy, walking difficulty and further reported death occurred long time after collar removal thus, not related to the product. 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 sign like death. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Other unrelated causes are likely in this case. Overall, product involvement is considered unlikely. K9advantix II small dog: Weight loss is not expected after product application. Though permethrin has the potential to cause slight neurological disorder like walking difficulty in walking in particular susceptible animals, it is not expected as time to onset is long. Lethargy is an unspecific sign and may be associated with walking difficulty. Death is not expected after topical product application as it is inconsistent with the pharmaco-toxicological product profile. Time to onset is more than 12 hours, therefore an allergic/anaphylactic-type reaction can be ruled out. Other causes are more probable in this dog. Time to onset is long. Overall, a product relation is considered unlikely. K9advantix II medium dog: Weight loss is not expected after product application. Though permethrin has the potential to cause slight neurological disorder like walking difficulty in walking in particular susceptible animals, it is not expected as time to onset is long. Lethargy is an unspecific sign and may be associated with walking difficulty. Death is not expected after topical product application as it is inconsistent with the pharmaco-toxicological product profile. Time to onset is more than 12 hours, therefore an allergic/anaphylactic-type reaction can be ruled out. Other causes are more probable in this dog. Time to onset is long. Overall, a product relation is considered unlikely. MGK Advantage Treatment Shampoo for Dogs and Puppies: None of the signs expected following appropriate use of the product. Even in case of oral ingestion would not expect severe sign like death. Product has a wide margin of safety. Moreover, in case of oral ingestion only small amounts are ingested and rather cause mild digestive tract disorders. In this case no oral ingestion witnessed or suspected. Product was well tolerated on a regular basis every two weeks over a period of approximately 7 months. Other products were administered concomitantly. Signs non-specific and rather related to impending death. Time to onset in this case unknown, since previous treatment date unknown. No necropsy performed. Overall, product relation rather unlikely, but due to insufficient information, product relation is considered unclassifiable.