New incident report
Incident Report Number: 2017-6500
Registrant Reference Number: USA-BAYERBAH-2017-US0035596
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
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar large
Other (specify)
collraYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
French Bulldog
1
Female
6
9.979
kg
Skin
>3 days <=1 wk / >3 jours <=1 sem
>3 days <=1 wk / >3 jours <=1 sem
System
Persisted until death
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 14-Jun-2017, a 6 year old, 22 pound, intact, female, French Bulldog canine, in unknown condition, with a concomitant medical condition of flea allergy dermatitis, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 18-Jun-2017, the dog exhibited a single seizure episode that resolved approximately 15 minutes post onset of clinical sign without medical intervention. On 20-Jun-2017, the dog exhibited a single seizure episode and approximately 5 minutes post onset of the clinical sign, the dog died. The dog was not examined by a veterinarian. No known necropsy was performed. No further information is expected; the case is closed. Follow up received on 20th June, 2017: On 20-Jun-2017, the dog exhibited a single seizure episode and approximately 5 minutes post onset of the clinical sign, the dog died. The dog was not examined by a veterinarian. No known 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. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. Other unrelated causes must be considered in this case. Time to onset is too long. Considering low level of information (animal health status and necropsy report), a product relation is unassessable.