New incident report
Incident Report Number: 2016-4265
Registrant Reference Number: 2016KP147
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
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar - Dog
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Miniature Poodle Crossbreed
1
Female
21
10
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in 2014, the canine gained weight to 15 pounds. The canine died. It was unknown if a necropsy examination 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 call was to discuss the use of the product on another pet and not to report the death of this canine. No further information is expected. This case is closed.
Death
Reported signs and particularly serious signs such as death are not expected following appropriate topical product application as inconsistent with product¿s pharmacological profile. Oral exposure to the collar is not expected to cause death 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. Further, the afffected animal was at an advanced age. The reported did not believe in a product connection either as in case of suspected product involvement signs would have been reported in close proximity and not a long time (2 years) later. Rather the reason for the initial call was to discuss the use of the product on another pet and not to report the death of this canine. Finally, although exact time to onset and status of necropsy were unknown, sufficient information was available to rule out product involvement and product relation was deemed to be unlikely.