New incident report
Incident Report Number: 2021-2423
Registrant Reference Number: USA-BAYERBAH-2021-US0009584 (Report 691374)
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 150 Research Lane, Suite 120
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G 4T2
Domestic Animal
Country: UNITED STATES
Prov / State: GEORGIA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto cat
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Domestic Shorthair
1
Male
2
3.175
kg
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 14-Dec-2020, the cat developed drooping eyelids, lethargy, his eyes became dull in color (iris disorder), and he would not play (behavioral disorder NOS). On 15-Dec-2020, the cat died. No necropsy was performed. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable Reported eye disorders are not expected after topical application of the product. No ocular exposure reported. Reported lethargy and behavioral disorder are unspecific and may have numerous other causes. Signs may occur initially after collar administration but are not expected to appear after long time. Time to onset too long. Death is not expected following appropriate topical product application as inconsistent with products 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset is long. Considering limited information (e.g. health status, medical history and necropsy are unknown), a product relation is unassessable.