New incident report
Incident Report Number: 2015-3777
Registrant Reference Number: 2015CK258
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Boulevard
City: Missisaugua
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. 1556-155
Product Name: Seresto Collar - large dog
Other (specify)
CollarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
labrador
1
Male
16
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
<=30 min / <=30 min
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 3-Apr-2015, the dog died. It is unknown if a 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 call to Bayer Animal Health was to discuss product use on another pet and not to report the death of this dog.
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 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Further the reason for the initial call to Bayer Animal Health was to discuss product use on another pet and not to report the death of this dog. Also involved animal is of old age hence other causes are more probable. Exact time to onset is unknown but seems long. Considering the known product profile, sufficient information exists to conclude that the product did not cause the event and product involvement was ruled out.