New incident report
Incident Report Number: 2021-0342
Registrant Reference Number: USA-BAYERBAH-2020-US0061237 (Report 679268)
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: ARIZONA
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
Animal's Owner
Dog / Chien
Pit Bull crossbred
1
Male
12
29.484
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>24 hrs <=3 days / >24 h <=3 jours
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 06 May 2020, the dog developed coughing up blood. The dog was examined by a veterinarian and was diagnosed with a bleeding in his throat, it is unknown if any treatments were performed. On approximately 01 Jun 2020, the dog died. No autopsy was performed.
Death
O - Unclassifiable/unassessable Product was suspected to be counterfeit. Nevertheless, for genuine product, reported coughing up blood, later diagnosed bleeding in the throat and death are not expected after product application as inconsistent with pharmaco-toxicological product profile. Other causes are more probable in this geriatric dog with unknown health condition. 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset is long. No autopsy was performed. Considering the product profile, product involvement is deemed unlikely, however taking into consideration all aspects, especially reported suspected counterfeit, the causality remains unassessable.