New incident report
Incident Report Number: 2021-2430
Registrant Reference Number: USA-BAYERBAH-2021-US0009968 (Report 691668)
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: NEW YORK
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
Crossbred ( Retriever - Golden x Collie)
1
Unknown
Unknown
Unknown
Skin
>6 mos <=1 yr / > 6 mois < = 1 an
>2 mos <=6 mos / > 2 mois < = 6 mois
System
Unknown / Inconnu
Yes
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 01-Jul-2019, the dog was evaluated by the veterinarian and was diagnosed with lymphoma. An unspecified dose of an unspecified chemotherapy drug was administered by the veterinarian. On approximately 01-Nov-2019, the dog died. No necropsy was performed. Due the sensitive nature of the communication, certain pertinent information was not obtained, nor will be sought. The intent of the call was to inquire about product use in general and not to report the death. No further information is expected. This case is closed.
Death
N - Unlikely Diagnosed lymphoma and later reported death of the dog 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 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. In this case, diagnosed lymphoma may be the cause of death. Time to onset is long. Further, the intent of the call was to inquire about product use in general and not to report the death. Overall, considering all aspects, product relation is unlikely.