New incident report
Incident Report Number: 2017-6513
Registrant Reference Number: USA-BAYERBAH-2017-US0049386
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar unknown
Other (specify)
COLLARYes
Other Units: Collar
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Crossbred (Dog)
1
Male
8
Unknown
Skin
>6 mos <=1 yr / > 6 mois < = 1 an
>6 mos / > 6 mois
System
Unknown / Inconnu
Unknown
Unknown
Died
Other / Autre
specify Unknown
(eg. description of the frequency and severity of the symptoms
On an unspecified date in Aug 2016, a 8 year old, of unknown weight, male, Dachshund/Beagle crossbred canine, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Dog Collar (unspecified) (Flumethrin-Imidacloprid) placed around the neck by the owner. On an unspecified date in Apr2017 the dog died from unspecified causes. It is unknown if the dog was examined by a veterinarian or 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 initial communication from the reporting party was to inquire about using the Seresto collar on a new pet and not to report this event. No further information is expected. This 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 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 intent of the call was to discuss product use on another pet and not to report the death of the dog. Time to onset is long. Other unrelated causes are more probable. Even though some information is not available (e.g. health status and necropsy report), considering known safety profile of the product a product relation is unlikely.