New incident report
Incident Report Number: 2017-4039
Registrant Reference Number: USA-BAYERBAH-2017-US0014058
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: VIRGINIA
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
Pug
1
Male
10
11.34
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
Unknown
Unknown
Died
Other / Autre
specify Unknown
(eg. description of the frequency and severity of the symptoms
On approximately 01-Sep-2016, a 10 year old, 25 pound, neutered, male, Pug 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 approximately 25-Sep-2016, the dog died and it was 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 phone call was to discuss the use of the product and not to report the death of the patient. No further information is expected. Case is closed.
Death
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 dogs for an 8 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 is long. Moreover, The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Even though some information is not available (health status, medical history and necropsy report), sufficient information exists to rule out product relation completely. Overall, a product relation is consider as unlikely.