New incident report
Incident Report Number: 2017-4030
Registrant Reference Number: USA-BAYERBAH-2016-US0037122
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: MICHIGAN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Collar Large
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Siberian Husky
1
Female
11
Unknown
Skin
>6 mos <=1 yr / > 6 mois < = 1 an
>6 mos / > 6 mois
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 29-Jun-2016, an approximately 11 year old, female, Siberian Husky canine, of unknown weight, reproductive status, and condition, with a concomitant medical condition of blindness, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On an unknown date, in Feb2017, the canine 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 was to discuss lost collar replacement for another dog in the household and was not to report the death of the patient. No further information is expected. This case is closed. SLEE
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. Moreover, the reason for the initial call was to discuss lost collar replacement for another dog in the household and was not to report the death of the patient. Involved animal was in advanced age (11 years) which was likely the cause of death. Time to onset is exceptionally long (almost 8 months). Although it is unknown if necropsy was performed, considering the known product profile sufficient information exists to conclude that the product did not cause the event. Hence, a product relation is deemed to be unlikely.