New incident report
Incident Report Number: 2018-2741
Registrant Reference Number: USA-BAYERBAH-2018-US0033804 (Report 499989)
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
7
1.814
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Persisted until death
Unknown
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 23-Mar-2018, the dog had a seizure for approximately 5 minutes and resolved. On approximately 28-Mar-2018, the dog exhibited lethargy and intermittent vomiting after drinking. Approximately 6 hours post onset, the dog was examined by veterinarian and the dog died during the exam. No necropsy was performed. No further information is expected, 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 seizure 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. Reported vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). No oral product exposure is reported in this case. Reported lethargy is likely associated with vomiting. Later reported death is also 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 is long. Other causes are more probable. Overall, a product involvement is considered unlikely.