New incident report
Incident Report Number: 2020-2827
Registrant Reference Number: USA-BAYERBAH-2020-US0027531 (Report 643698)
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: MICHIGAN
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Large Dog
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Medical Professional
Dog / Chien
Great Dane
1
Male
4
61.779
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 10Jun2020, the dog had a seizure, was disoriented, became agressive and bit the owner. Then the dog ran off and ran until he collapsed and died. No necropsy was performed and the remains had been cremated. No further information is expected this case is closed.
Death
O - Unclassifiable/unassessable The product is not anticipated to cause serious neurological disorder of seizure after appropriate topical product administration as the controlled release mechanism assures release of only low doses of active ingredient at a time. But seizure was 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. Additionally reported disorientation and behavioural signs are most likely associated with seizures. Subsequently reported serious signs of collapse and death are not expected following appropriate topical product application as inconsistent with product¿¿¿¿¿¿s pharmaco-toxicological profile. Time to onset is long and other causes could have play a role, although not reported. Considering all aspects, a product relation is unassessable.