New incident report
Incident Report Number: 2019-3159
Registrant Reference Number: USA-BAYERBAH-2019-US0025243 (Report 566711)
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: NORTH CAROLINA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Large Dog (Flumethrin-Imidacloprid) collar
Other (specify)
COLLARYes
Unknown
Site: Animal / Usage sur un animal domestique
No
Animal's Owner
Cat / Chat
Domestic Shorthair feline
1
Female
4
4.082
kg
Skin
Unknown / Inconnu
>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 19-May-2019, the cat exhibited seizures, dilated pupils, epistaxis, and died. The cat was not examined by a veterinarian and no necropsy was performed. No more information is expected and this case is closed.
Death
N - Unlikely The product is not anticipated to cause serious neurological disorders such as seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Dilated pupils are likely associated with reported seizure. Additionally reported, epistaxis in not expected after product exposure. Reported fatal outcome of death is also not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Time to onset long. Exposure of the cat to the dog wearing the collar or the collar was not even clear. Other causes are more likely. Overall, a product relation is considered as unlikely.