New incident report
Incident Report Number: 2017-2236
Registrant Reference Number: 2017KP175
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: UNKNOWN
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar - Large Dog
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Standard Poodle
1
Male
14
62
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Persisted until death
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 16-Mar-2017, the dog exhibited seizures and died. No necropsy was performed. The reason for the call was to discuss the use of Seresto on his current pets and not to report the death of the patient. No further information is expected. This case is closed. Follow up recieved on 16th Mar 2017: On approximately 16-Feb-2017, the dog exhibited seizures and died.
Death
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. Overdose of 5 collars around the neck of adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period did not cause serious signs either. Merely gastrointestinal signs would be possible. 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. Further, 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. Dog involved in this case was geriatric and thus other unrelated causes must be considered. Death may be the consequence of seizure. The reason for the call was to discuss the use of product on his current pets and not to report the death of the patient. Time to onset short, though. Although product involvement is considered unlikely, due to limited information (e.g. no necropsy), a product relation is unassessable.