New incident report
Incident Report Number: 2017-4960
Registrant Reference Number: USA-BAYERBAH-2017-US0048382
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: NEW YORK
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Large Dog
Other (specify)
CollarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Labrador Retriever
1
Female
7
27.216
kg
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 mo <=2 mos / > 1 mois < = 2 mois
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Approximately 3 months post application, in Jun2017, the dog died. No known necropsy was performed.
Death
This case is closed. The initial call to Bayer Animal Health was not to report this event but to discuss product application on additional pets within the household. N-Unlikely: 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. Moreover the reason for the initial phone call was to discuss product application on additional pets within the household and not to report the death in this event. Time to onset is too long. Considering the known safety profile of the product, sufficient information exists to rule out product relation completely. Overall, a product relation is consider as unlikely.