New incident report
Incident Report Number: 2020-5408
Registrant Reference Number: USA-BAYERBAH-2020-US0038307 (Report 655202)
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: OHIO
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
Unknown
Animal's Owner
Dog / Chien
unknown
1
Male
Unknown
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
Yes
Yes
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 01-Jun-2020, the dog was hit by the car and sustained unspecified trauma. The dog was evaluated by the veterinarian, and unknown treatments were performed. The dog died. No necropsy was performed. The reporting party did not call to report the death of this animal, but to inquire about product use in general. No further information is expected. This case is closed. Follow up received on 29-Aug-2020: On approximately 01-May-2017, a male dog of unknown signalment, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the animal owner. On approximately 01-Jun-2017, the dog was hit by the car and sustained unspecified trauma. The dog was evaluated by the veterinarian, and unknown treatments were performed. The dog died. No necropsy was performed. The reporting party did not call to report the death of this animal, but to inquire about product use in general.
Death
N - Unlikely Trauma and death are not expected following appropriate topical product application as inconsistent with product¿¿¿¿¿¿s 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. Time to onset is long. However , in this case the dog was hit by a car and sustained unspecified trauma which likely resulted in his death. Furthermore, the intent of the call was to inquire about product use in general and not to report this event. Finally, product involvement is considered to be unlikely.