New incident report
Incident Report Number: 2016-4273
Registrant Reference Number: 2016KP154
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 - Cat
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Cat / Chat
Unknown
1
Male
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
At an unspecified time post application, in 2016, the cat died. It is unknown if a necropsy was performed. Due to the sensative nature of the communication, limited information was obtained at the time of the call. Further attempts to gather additional information will not be made. The reporting party contacted Bayer Animal Health to inquire about a replacement collar and not to report the death of this animal.
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 signs 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. Other causes are more likely. Pet with medical history of convulsive disorders which may be cause for death as well. Further, the owner did not believe in product involvement either as reason for the initial call was to inquire about a replacement of the collar and not to report the death of the patient. Considering these aspects, in spite of the limited information (animal details, time to onset, absence of necropsy results), considering known safety profile of the product, product relation is unlikely.