New incident report
Incident Report Number: 2020-5416
Registrant Reference Number: USA-BAYERBAH-2020-US0040657 (Report 657660)
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 Cat
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Cat / Chat
Unknown
1
Unknown
Unknown
Unknown
Skin
>6 mos <=1 yr / > 6 mois < = 1 an
>2 mos <=6 mos / > 2 mois < = 6 mois
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in approximately Jul2020, the feline exhibited unspecified systemic signs and vocalization. She was examined by an emergency veterinarian and was diagnosed with an enlarged heart and liver failure. It is unknown what treatments, if any, were instituted. On approximately 21Jul2020, the feline passed away. A necropsy was not peformed. No further information expected. Case closed.
Death
O - Unclassifiable/unassessable This collar is suspected counterfeit. Nevertheless, for genuine product reported unspecified systemic signs and vocalization are unspecific and may have numerous other causes. Signs may occur initially after collar administration but are not expected to appear after long time. Time to onset is too long. Other causes are more probable. Later reported serious signs of enlarged heart, liver failure and fatal outcome of 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. Time to onset is too long. Although no necropsy performed, product involvement is not likely, however due to limited information of case and taking into consideration all aspects, especially reported suspected counterfeit, the causality remains unassessable.