New incident report
Incident Report Number: 2021-2438
Registrant Reference Number: USA-BAYERBAH-2021-US0010172 (Report 691909)
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 150 Research Lane, Suite 120
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G 4T2
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto large dog
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
unknown
1
Female
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 unspecified date post application, in approximately 2021, the canine exhibited unspecified malaise and an unspecified liver disorder; the Seresto collar was removed. It is unknown if the canine was examined or treated by a veterinarian. On an unknown date post collar removal, in approximately 2021, the canine died. It is unknown if a necropsy was performed. No further information expected. Case closed.
Death
O - Unclassifiable/unassessable Reported malaise is not expected after product application. Further, unspecified liver disorder and fatal outcome of death are not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause such 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 week old puppies for a 6 months period without causing serious signs. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Considering the product profile, product involvement is deemed unlikely, however due to limited information (e.g: animal health status, necropsy details, onset time) case is considered unassessable.