New incident report
Incident Report Number: 2019-5094
Registrant Reference Number: USA-BAYERBAH-2019-US0051305 (Report 593407)
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: MICHIGAN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: advantageII pipette size unknown
Other (specify)
spot onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Other
Cat / Chat
unknown
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On unknown date post application, in 2019, the feline exhibited a seizure. The feline was presented to the clinic and died. No necropsy was performed. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable Serious nervous system disorders such as seizures are not anticipated with topical administration of 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 seizures 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. Unknown whether seizures were confirmed by vet or only observed by owner. Further reported death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Oral exposure to the product is not expected to cause serious conditions. 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. Death may have been the result of seizures. Nevertheless, other causes must also be considered although not described. Considering low level of information regarding necropsy, time to onset and animals details, product involvement is deemed to be unassessable.