New incident report
Incident Report Number: 2017-6446
Registrant Reference Number: USA-BAYERBAH-2017-US0052096
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: NORTH CAROLINA
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
Unknown
Animal's Owner
Dog / Chien
Unknown
1
Unknown
Unknown
Unknown
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 01-Jun-2017, a canine of unknown signalment and condition, with no known concomitant medical conditions, had one Seresto Large Dog collar (Flumethrin-Imidacloprid) placed around the neck by the animal owner. On approximately 07-Aug-2017, the dog died. No known necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sough. The reason for the initial call was to discuss if the product could be stored and used at a later time and not to report the death in this event. No new information is expected. This case is closed.
Death
N - Unlikely Death is not expected following appropriate topical product application as it is 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 is long. Moreover, the intent of the call was to inquire about using the collar on another pet and not to report the death of the dog. Considering the known product profile sufficient information exists to conclude that the product did not cause the event. Overall, product involvement is unlikely.