New incident report
Incident Report Number: 2017-4018
Registrant Reference Number: USA-BAYERBAH-2017-US0021409
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: VIRGINIA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Small
Other (specify)
collarYes
Other Units: cm
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Yorkshire Terrier
1
Male
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in 2016, a male, Yorkshire Terrier canine, of unknown signalment, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Small Dog Collar (Flumethrin-Imidacloprid) placed around the neck by the owner. On approximately 21Apr2017, the dog died. No known medical exams werer performed and it was 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 phone call was to discuss the use of the product and not to report the death of the patient. No further information is expected. This case is closed. Note: Previous applications were well tolerated.
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 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. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time. Moreover, the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Time to onset long. Also, animal had used product before which was well tolerated. Though some information is unavailable (state of health and necropsy detail) considering the known product safety profile, a product involvement is considered unlikely.