New incident report
Incident Report Number: 2017-4475
Registrant Reference Number: USA-BAYERBAH-2017-US0028996
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 Collar unknown
Other (specify)
collarYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Unknown
1
Female
15
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
Yes
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 10-May-2017, a 15 year old, of unknown weight, unknown, female, Unknown (dog) dog, in unknown condition, with concomitant medical conditions of 1 past seizure, had 1 collar Seresto (unspecified) (Flumethrin-Imidacloprid) placed around the neck by the animal owner. On 27May2017 the dog a seizure. On 28May2017 the dog had 2 seizures and the collar was removed.The dog was bathed with dish soap as per veterinarian instructions via a phone consultation. On 30May2017, the dog passed away. No necropsy was performed. Follow up received on 5th May 2017: On 30May2017, the dog died. No necropsy was performed. No more information is expected. This case is closed.
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 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. As pet showed seizures prior to product use, seizures are likely related to this underlying condition. It is known that despite adequate treatment, seizures may occur and medication must be adapted every now and then to control the disease. 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. Reported death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause serious sign either. Dog involved in this case was geriatric thus numerous other health problems have to be considered in this dog. Finally, even though some information (e.g. necropsy results) is not available, considering known safety profile of the product and fatal outcome, a product involvement is deemed to be unlikely.