New incident report
Incident Report Number: 2021-2425
Registrant Reference Number: USA-BAYERBAH-2021-US0009664 (Report 691436)
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 Longhair
1
Male
2
4.536
kg
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>6 mos / > 6 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 01-Jan-2021, the cat developed drooping eyelids and had difficulty opening his eyes (eye disorder NOS). On 02-Jan-2021, the cat developed lethargy, panting, dehydration, ataxia, dyspnea and impaired consciousness. The veterinarian was consulted and an unknown amount of an electrolyte drink was administered via the oral route by the animal owner. On 03-Jan-2021, the cat died. No necropsy was performed. The case is closed, no further information is expected.
Death
O - Unclassifiable/unassessable Reported eye disorders are not expected following appropriate application as inconsistent with products pharmacological profile. Reported lethargy and panting are unspecific signs and may have numerous other causes. Signs may occur initially after collar administration but are not expected to appear after long time. Ataxia, dehydration, dyspnea, impaired consciousness and later reported serious sign death are not expected following appropriate 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. No necropsy was performed. Time to onset is long for all reported signs. Hence, other causes should be considered. Overall, considering all aspects, a product relation is unassessable.