New incident report
Incident Report Number: 2021-3181
Registrant Reference Number: USA-BAYERBAH-2021-US0017748 (Report 698486)
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: KENTUCKY
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar Small dog
Other (specify)
COLLARYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Unknown
1
Unknown
14
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>24 hrs <=3 days / >24 h <=3 jours
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 12Apr2021, the canine developed ataxia, seizures, and was diagnosed with renal failure. It was unknown if treatments were performed. On 30-Apr-2021, the dog died. No necropsy was performed.
Death
O - Unclassifiable/unassessable The product is not anticipated to cause seizures after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. Renal failure is not in with pharmaco-toxicological product profile. 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. Seizure may be associated with diagnosed renal failure in this geriatric animal. Further reported ataxia is likely associated with seizure. Time to onset is short. Diagnosed renal failure and death are not expected with topical product application. It is not in line with pharmaco-toxicological product profile. Animal might have died due to renal failure. No necropsy was performed. Time to onset is long. Overall product relation is considered as unassessable.