New incident report
Incident Report Number: 2015-3807
Registrant Reference Number: 2015KP210
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
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar - Unknown
Other (specify)
CollarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Unknown
Other
Dog / Chien
Unknown
1
Unknown
Unknown
Unknown
Skin
>6 mos <=1 yr / > 6 mois < = 1 an
>6 mos / > 6 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date post collar application, in approximately September 2014, the dog died. It is unknown if a necropsy was performed. No further information is expected. This case is closed. 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 a current flea issues with 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. Very low level of information : age, medical history and necropsy not available. The reason for the initial phone call was to discuss a current flea issue with another pet and not to report the death of this dog. The time to onset is unknown, however seems too long. Thus, other unrelated etiologies more probable. Considering the provided data, sufficient information exists to confirm that the product did not cause the event and product involvement was considered to be unlikely.