New incident report
Incident Report Number: 2020-5475
Registrant Reference Number: USA-BAYERBAH-2020-US0051851 (Report 669374)
Registrant Name (Full Legal Name no abbreviations): Elanco
Address: 150 Research Lane
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 collar Cat
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Unknown
1
Female
8
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in 2019 post collar placement the cat developed application site alopecia and application site irritation. The owner removed the collar. On an unspecified date in 2020 the cat developed weight loss, cancer and died. It is unknown if the cat was examined by a veterinarian or if a necropsy was performed.
Death
O - Unclassifiable/unassessable The reported application site disorders may occur in sensitive animals after product application. They are usually mild and transient. Signs are consistent. Further weight loss, cancer 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. Other unrelated causes must be considered for serious signs. Considering low level of information (e.g. Health status, medical history, time to onset and necropsy report are unknown). Overall, a product relation is considered unassessable.