New incident report
Incident Report Number: 2021-2632
Registrant Reference Number: USA-BAYERBAH-2021-US0017239 (Report 697944)
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
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto small dog
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Crossbred ( Pomeranian x Poodle (Miniature))
1
Male
10
5.443
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
No
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 12Apr2021 the dog developed ataxia and shaking. On 20Apr2021 the dog had a seizure that lasted an unspecified length of time. On 22Apr2021 the dog was examined by a veterinarian and no treatment was completed. On 26Apr2021 the dog developed anorexia and adipsia. The owner removed the collar and the dog was bathed with an unspecified shampoo. On 28Apr2021 the dog died and no necropsy was performed. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable Reported ataxia is not typically seen with appropriate topical product administration. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Shaking is not expected with product application but is likely associated with reported ataxia. Further, 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. Seizures were not verified by veterinarian neither any treatments were performed. Reported anorexia and adipsia are unspecific and may have numerous other causes. Signs are not expected to occur long time after collar application. Further, 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 signs either. No serious signs reported in close proximity to death. Time to onset is long. Animal's health status and medical history if any is unknown. Also, no necropsy was performed. Other unrelated causes must be considered in this geriatric dog. Considering overall aspect, product relation to the case is unassessable.