New incident report
Incident Report Number: 2019-6465
Registrant Reference Number: USA-BAYERBAH-2019-US0064169 (Report 606768)
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: TEXAS
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Chihuahua
1
Male
13
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 15-Jul-2019, the dog exhibited a seizure and resolved in approximately 1 minute. On approximately 29-Jul-2019, the dog exhibited 3 seizures which resolved in approximately 5 minutes. The collar was removed by the owner. On 22-Oct-2019, the dog had visible fleas and the same collar was reapplied. On 23-Oct-2019, the dog exhibited a seizure and resolved in approximately 1 minute. The collar was removed by the owner. On 24-Oct-2019, the dog had multiple seizures and died.
Death
[MAH (GDS)]: 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 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. Other causes are more likely. Time to onset is long after initial collar application. Fleas were reported long time after collar removal. Hence not related to product. Further reported death is not expected with appropriate collar application. It is not consistent with pharmaco-toxicological product profile. Time to onset is short for later reported seizure and subsequent death after reapplication of collar. However other underlying causes should be considered for this geriatric dog. Product involvement is considered unassessable.