New incident report
Incident Report Number: 2020-2833
Registrant Reference Number: USA-BAYERBAH-2020-US0029664 (Report 645871)
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: MISSISSIPPI
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar unknown
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Miniature Poodle
1
Female
Unknown
4.082
kg
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
No
Died
Contact treat.area/Contact surf. traitée
(eg. description of the frequency and severity of the symptoms
On an unspecified date in 2020 post collar placement, the dog developed inappetence, a behavioral change, lethargy, weight loss, vomiting, and seizures. The dog was examined by a veterinarian and it is unknown if any treatment was preformed. On an unspecified date in 2020 post veterinary exam, the dog died. It is unknown if a necropsy was preformed. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable Reported inappetence, behavioral change and lethargy and weight loss are unspecific and may have numerous other causes. Vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Time to onset of signs is unknown. Reported signs maybe associated with further reported seizures. 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. However, it is known that overdose of 5 collars around the neck of adult dogs for an 8-month 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. Further reported fatal outcome of death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile and most likely consequence of the reported seizures. However, considering most of the information is not available (animal age, health status, time to onset and necropsy report), product relation is assessed as unassessable.