New incident report
Incident Report Number: 2020-5413
Registrant Reference Number: USA-BAYERBAH-2020-US0040143 (Report 657101)
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 150 Research Lane, Suite 120
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G4T2
Domestic Animal
Country: UNITED STATES
Prov / State: OHIO
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
Other
Cat / Chat
Unknown
1
Female
12
Unknown
Skin
>6 mos <=1 yr / > 6 mois < = 1 an
>6 mos / > 6 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 04-Aug-2019, the cat developed lethargy and intermittent emesis. The cat died. The collar was removed. No necropsy was performed. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable Reported emesis is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Though mild gastrointestinal signs may occur shortly after product application, they are not expected to appear with long time to onset. No oral product exposure reported. Lethargy is likely associated with reported emesis. Further, death is 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. Further, health status of cat is unknown and no necropsy was performed. Other causes should be considered in this geriatric cat. Time to onset is long. Overall, product involvement is considered unassessable.