New incident report
Incident Report Number: 2016-0747
Registrant Reference Number: 2015KP375
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
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Irish Red Setter
1
Male
10.5
Unknown
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 post collar application, in May 2015, the dog died. It is unknown if the dog was euthanized or 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 call was to discuss product use on his other dogs and not to report the death of the patient.
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 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. Animal involved in this case was geriatric, which may have further contributed to death of the animal. Further, the owner did not believe in product involvement either as the reason for the initial call was to discuss product use on his other dogs and not to report the death of the patient. Even though some information is missing (e.g. unknown whether animal euthanized or necropsy was done, health status and medical history of the animal, time to onset) sufficient information exist to ruled out product relation completely. Considering all aspects, a product relation is unlikely.