New incident report
Incident Report Number: 2016-6705
Registrant Reference Number: 2016KP263
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
Unknown
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
Other
Dog / Chien
Unknown
1
Unknown
Unknown
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date post application, in 2016, the dog died of unknown causes. No known necropsy was performed. The reason for the initial call to Bayer was to inquire about use of the product on other animals; not to report the death of this animal. No more information is expected; this case is closed.
Death
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 sign either. An overdose of 5 collars around the neck was investigated in 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 without causing serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. The reason for the initial call to Bayer was to inquire about use of the product on other animals and not to report the death of this animal. Even though some information is not available (animal health status, medical history, exact time to onset and necropsy report) considering the known product profile sufficient information exists to ruled out product relation completely. Finally, a product relation is considered as unlikely.