New incident report
Incident Report Number: 2020-2834
Registrant Reference Number: USA-BAYERBAH-2020-US0029791 (Report 646251)
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: UNKNOWN
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
10
7.27
kg
Skin
>2 hrs <=8 hrs / >2 h <=8 h
>2 hrs <=8 hrs / > 2 h < = 8 h
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Approximately 3 hours post application, the cat developed an unspecified abnormal behavior. The animal owner removed the collar from the cat. On 20-Jun-2020, the cat developed a seizure and died. No necropsy was performed on the cat. No further information is expected. This case is closed. Note: The intent of the call was to inquire about product use in general and not to report this event.
Death
O - Unclassifiable/unassessable Reported abnormal behaviour unspecific and may have numerous other causes. Sign may occur initially after collar administration. Time to onset is short. Sign may be associated with further reported seizure. 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. But seizures 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. Further reported fatal outcome of death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile and most likely be the consequence of the reported seizure in this old age cat. Time to onset is short. Overall, product involvement is considered unassessable.