New incident report
Incident Report Number: 2020-5484
Registrant Reference Number: USA-BAYERBAH-2020-US0055069 (Report 672637)
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: KENTUCKY
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar Small Dog
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Chihuahua
1
Female
7
3.175
kg
Skin
>24 hrs <=3 days / >24 h <=3 jours
>24 hrs <=3 days / >24 h <=3 jours
System
Unknown / Inconnu
Yes
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 19-Oct-2020, the dog developed emesis (multiple), polydipsia, and hemorrhagic diarrhea. On 20-Oct-2020, the dog exhibited impaired consciousness and her eyes stopped blinking (eye disorder NOS). The dog was evaluated by a veterinarian, blood work was performed, fluids were administered, and the dog died.
Death
O - Unclassifiable/unassessable Reported digestive signs are unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Though mild gastrointestinal sign like vomiting may occur shortly after product application, other more severe gastrointestinal sign like hemorrhagic diarrhea is not typically seen with product use. No oral product exposure reported. Other causes have to be considered. Polydipsia is unspecific, however in this case it might be associated with digestive signs. Other reported signs (impaired consciousness, eyes stopped blinking 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 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Considering short time to onset and no necropsy was performed. In summary, a product involvement for the case is unassessable.