New incident report
Incident Report Number: 2016-6718
Registrant Reference Number: 2016KP276
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: UNKNOWN
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Unknown
1
Female
14
27
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 01-Nov-2015, the canine was examined by a veterinarian who diagnosed an unspecified cancer. On approximately 01-Feb-2016, the owner removed the collar as it had reached its duration and the canine had 1 new Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On approximately 01-Jun-2016, fleas were seen, so the owner removed the collar and placed 1 new Seresto Dog (unspecified) (Flumethrin-Imidacloprid) around the neck of the canine. On 15-Jul-2016, the canine died. No known necropsy was performed. No further information is expected. This case is closed.
Death
SLEE/fleas. Reported cancer and death are not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause such 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. Animal was reported to be in advanced age. Death may be the likely consequence of earlier diagnosed cancer in an animal. Further the owner did not believe in product involvement either as the reason for initial call was to inquire about collar efficacy for the other dogs in the household and not to report the death of this animal. Presence of fleas is not a sign of inefficacy. Product is not a repellent. Fleas have to be on the animal to come into contact with the product to be killed. Fleas were reported after a flea-free time. Sudden appearance of fleas after flea-free time suggests re-infestation with fleas from environment (e.g. other untreated pets, wildlife). This may lead to new establishment of a flea population in pets environment requiring several weeks of treatment to disappear. Time to onset is quite long for the reported serious events. Although no necropsy was performed sufficient information exist that the product involvement is unlikely.