New incident report
Incident Report Number: 2017-6508
Registrant Reference Number: USA-BAYERBAH-2017-US0046234
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: TENNESSEE
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
Fox Terrier (Smooth)
1
Female
11
13.608
kg
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 an unknown date in Dec 2016, a 11 year old, 30 pound, unknown, female, Fox Terrier 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 an unknown date in Mar2017, the canine died and no necropsy was performed. No more information is expected this case is closed. The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient.
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. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. However, animal involved in this case was geriatric. Moreover, the owner did not believe in product involvement either as the reason for the initial phone call was to discuss the use of the product on another pet and not to report the death of the patient. Time to onset is long. Finally, even though some information (e.g. necropsy results) not available, considering known product profile, a product involvement is deemed to be unlikely.