New incident report
Incident Report Number: 2021-2428
Registrant Reference Number: USA-BAYERBAH-2021-US0009915 (Report 692126)
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: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar unknown
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
unknown
1
Female
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in 2019, the canine developed seizures. The dog was evaluated by a veterinarian and bloodwork showed a high white blood count. The dog was placed on an unknown antibiotic. On an unknown date in Jan 2020 the dog passed away. No necropsy was performed. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable The product is not anticipated to cause serious neurological disorders such as seizures and finally led to death after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. But seizures/convulsions were reported in connection with product use in dogs. However, it is known that overdose of 5 collars around the neck of adult dogs for an 8 months period and in 7 week old puppies for a 6 months period did not cause 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. Even with oral product exposure, seizures are not seen. Merely gastrointestinal signs may occur. Any action or treatment may trigger seizures in an animal with a respective disposition. Various etiologies exist for seizure events or paroxysmal signs, e.g. heart disorder, development disorder, metabolic disorder, infection, intoxication, idiopathic epilepsy, trauma, neoplasms. Time to onset unknown. Leucocytosis not expected, may point toward another underlying disease. Considering that many factors are unknown in this case animal details (age, weight, health status), product details, onset time, necropsy results etc, a reliable causality is not possible and a product involvement is considered unassessable.