New incident report
Incident Report Number: 2020-2252
Registrant Reference Number: USA-BAYERBAH-2020-US0024688 (Report 640026)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: UNITED STATES
Prov / State: LOUISIANA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-130
Product Name: advantageII extra large dog
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
No
Animal's Owner
Dog / Chien
Australian Cattle Dog, Heeler
1
Male
10
24.948
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 29-May-2020, the dog exhibited a seizure, urinary incontinence, collapsed and died. The dog was not evaluated by a veterinarian; no autopsy was performed.
Death
O - Unclassifiable/unassessable Serious nervous system disorders such as seizure and collapse are not anticipated with topical administration of the product. From a toxicological point of view, neither imidacloprid nor pyriproxyfen does have the potential to provoke seizures in vertebrates. In case of oral ingestion of a considerable amount of product or after administration of an overdose shortly after product application, neurological symptoms such as tremor, ataxia, depression, miosis or mydriasis may occur. But serious signs are not expected. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Further reported urinary incontinence likely associated with seizures. Reported death is also not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions leading to death either. The product was administered to puppies/kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments and there were no serious safety concerns. Time to onset is long. Other causes should be considered in this geriatric dog. Overall, product involvement is deemed to be unassessable.