New incident report
Incident Report Number: 2018-2742
Registrant Reference Number: USA-BAYERBAH-2018-US0033814 (Report 499997)
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: SOUTH CAROLINA
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
Pomeranian
1
Female
6
2.948
kg
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 mo <=2 mos / > 1 mois < = 2 mois
System
Persisted until death
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 15-May-2018, the dog had a seizure for approximately 5 minutes and resolved. The dog was examined by the veterinarian, however, no treatments were performed. The, the collar was removed, dog was bathed in an unknown shampoo by the groomer and the hair mats were removed. On approximately 4-Jun-2018, the dog had the same Seresto Small Dog collar replaced around the neck by the owner. On approximately 7-Jun-2018, the dog exhibited a seizure and then died. No necropsy was performed. No further information is expected, case is closed.
Death
O - Unclassifiable/unassessable 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 was reported in connection with product use in dogs and were requested by authorities to be content of the EU SPC. 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. Death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. 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. Time to onset long. Other causes must be considered in dog with congenital musculoskeletal disorder. Product involvement is considered unassessable.