New incident report
Incident Report Number: 2017-4463
Registrant Reference Number: USA-BAYERBAH-2017-US0026161
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: FLORIDA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Small
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Chihuahua Crossbred (Dog)
1
Female
14
6.35
kg
Skin
>3 days <=1 wk / >3 jours <=1 sem
>3 days <=1 wk / >3 jours <=1 sem
System
>24 hrs <=3 days / >24 h <=3 jours
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 13-Apr-2017, a 14 year old, 14 pound, neutered, female, Chihuahua crossbred dog, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Small Dog collar (Flumethrin-Imidacloprid) placed around the neck by the animal owner. On 16Apr2017 the dog had one seizure lasting approximately 5 minutes. The dog was evaluated by a veterinarian and administered an injection of an unknown medication and intravenous fluids. The dog improved and was discharged. On 18Apr2017 the dog had a second seizure lasting approximately 15 minutes and then died. No necropsy was performed.
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 were reported in connection with product use in dogs and were requested by authorities to be content of the EU SPC. 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. 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. Subsequently reported death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Animal involved in this case was geriatric and other unrelated causes must be considered. Time to onset is long. Finally, product involvement was considered unassessable.