New incident report
Incident Report Number: 2017-4915
Registrant Reference Number: USA-BAYERBAH-2017-US0039850
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: MISSOURI
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
Animal's Owner
Dog / Chien
English Pointer
1
Male
0.75
18.14
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
>24 hrs <=3 days / >24 h <=3 jours
Yes
Unknown
Died
Other / Autre
specify Unknown
(eg. description of the frequency and severity of the symptoms
On approximately 19-Jun-2017, a 9 month old, 40 pound, intact, male, Pointer canine, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On 01-Jul-2017, the dog exhibited anorexia, vomiting, and lethargy. On 02-Jul-2017, the owner placed an unspecified electrolyte and vitamin replacement product into the dog's water. On 03-Jul-2017, the dog died. No 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 was to discuss use of the product not to report the death in this event.
Death
N - Unlikely Vomiting is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Mild gastrointestinal sign may occur shortly after product application, however, time to onset long with nearly 2 weeks. No oral product exposure reported. Additionally reported systemic signs are likely related to reported vomiting. 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. Time to onset long. Moreover the reason for the initial call was to discuss use of the product not to report the death in this event. Even though no necropsy results available, considering the known product profile sufficient information exists to conclude that the product did not cause the event and product involvement was considered unlikely.