New incident report
Incident Report Number: 2021-4678
Registrant Reference Number: USA-BAYERBAH-2021-US0032964 (Report 715442)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: UNITED STATES
Prov / State: 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
No
Animal's Owner
Cat / Chat
Unknown
3
Unknown
0.13
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 approximately 20-Jul-2021, the 7 week old kittens had severe flea infestations and died. It is unknown if necropsies were performed.
Death
O - Unclassifiable/unassessable In this case collar was applied on adult cat and kittens secondarily exposed to collar and hence presence of fleas is not a sign of inefficacy. Also, kittens had concomitant medical condition of fleas. Further, death is not expected following appropriate topical product application as inconsistent with products 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. The safety of the veterinary medicinal product has not been established in target animal during pregnancy and lactation however laboratory studies with either flumethrin or imidacloprid in rats and rabbits have not produced any effects on fertility or reproduction and showed no teratogen or foetotoxic effects.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 exposure to the collar. Considering limited information (e.g. health status, time to onset and necropsy results are unknown), a relation to this case is unassessable.