New incident report
Incident Report Number: 2015-6305
Registrant Reference Number: 2015KP311
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
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
Riesenschnauzer
1
Female
10
90
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
>1 wk <=1 mo / > 1 sem < = 1 mois
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 25May2015, the canine had an unspecified neoplasia and died. It was unknown if medical intervention was sought or if a necropsy examination was performed. The reason for the initial call was to discuss the use of the product on another pet in the household and not to report the death of this canine. No further information is expected. This case is closed.
Death
The reason for the initial call was to discuss the use of the product on another pet in the household and not to report the death of the canine. Nevertheless neoplasia and death are inconsistent with pharmaco-toxicological product profile and experience. Oral exposure to the collar is not expected to cause such signs either. An overdose of 5 collars around the neck was investigated in adult dogs for an 8 months period and in 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. Death has most probably consequence of the unspecified neoplasia. Considering the known product profile and long time to onset (25 days), sufficient information exists to conclude that the product did not cause the event and thus product involvement is considered to be unlikely.