New incident report
Incident Report Number: 2016-6707
Registrant Reference Number: 2016KP265
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
English Cocker Spaniel
1
Male
12
45.5
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
System
Unknown / Inconnu
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 07 Sep 2016, the dog was examined by a veterinarian, was diagnosed with congestive heart failure and died. No necropsy 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 phone call was to discuss the use of the product and not to report the death of the patient. No more information is expected. Case is closed.
Death
Reported congestive heart failure and 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. Outcome may be the consequence of the diagnosed congestive heart failure and thus, sufficient information exists to rule out product involvement. Time to onset long. Further, the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Considering the known product profile sufficient information exists to conclude that the product did not cause the event and product involvement was ruled out. Overall, product involvement is considered unlikely.