New incident report
Incident Report Number: 2015-3757
Registrant Reference Number: 2015CK238
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Boulevard
City: Missisaugua
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. 1556-155
Product Name: Seresto Collar - cat
Other (specify)
CollarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Cat / Chat
unknown
1
Female
10
Unknown
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date post collar application, in Nov 2014, the cat had a seizure and died. It is unknown if a necropsy was performed.Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call to Bayer Animal Health was to discuss other pets in household and not to report the death of this cat.
Death
N - Unlikely. 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. 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 seizure or death either. An overdose of 5 collars around the neck was investigated in adult cats for an 8 months period and in 10 week old kittens 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. Collar was worn for approx 5 months without causing any adverse signs. No known necropsy was performed. The reason for the initial call to Bayer Animal Health was to discuss other pets in household and not to report the death of this cat. Considering the known product profile and extremely long time to onset (approximately 5 months), sufficient information exists to conclude that the product did not cause the event and thus product involvement is unlikely.