New incident report
Incident Report Number: 2017-0582
Registrant Reference Number: 2017KP085
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 - Large Dog
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Golden Retriever
1
Unknown
Unknown
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>6 mos / > 6 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 01Jan2016, the dog died and 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 additional information expected. This case is closed.
Death
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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset long. Considering the known product profile sufficient information exists to conclude that the product did not cause the event. Furthermore the owner called to inquire about product use and not to report death. Although no necropsy performed, product involvement is considered unlikely.