New incident report
Incident Report Number: 2017-6452
Registrant Reference Number: USA-BAYERBAH-2017-US0052759 (Report 439821)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: TENNESSEE
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
Animal's Owner
Dog / Chien
Crossbred
1
Male
11
40.823
kg
Skin
Unknown / Inconnu
>6 mos / > 6 mois
System
>8 hrs <=24 hrs / > 8 h < = 24 h
Unknown
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 25 Jul 2017, the dog had a seizure and died at home. No known necropsy was performed.
Death
N-Unlikely: 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/convulsions were reported in connection with product use in dogs and were requested by authorities to be content of the EU SPC. 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. 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 death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Moreover, signs were reported a long time (approximately 2 years) after collar removal. Time to onset not suggestive of product involvement. Other causes are more probable. Product involvement is considered unlikely.