New incident report
Incident Report Number: 2020-0796
Registrant Reference Number: USA-BAYERBAH-2020-US0003902 (Report 619683)
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: MASSACHUSETTS
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
Animal's Owner
Cat / Chat
Domestic Medium Hair
1
Male
20
Unknown
Skin
Unknown / Inconnu
>24 hrs <=3 days / >24 h <=3 jours
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Approximately 3 days post application, in 2017, the cat exhibited application site erythema, application site rash and application site alopecia. The collar was removed. On an unspecified date in application, in approximately 2017, the clinical signs resolved. On an unspecified date in approximately 2017, the cat died. It is unknown if a necropsy was performed. No further information is expected. The case is closed.
Death
O - Unclassifiable/unassessable The reported application site disorders may occur in sensitive animal after product application. They are usually mild and transient. Time to onset is short. 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Moreover, sign occurred after collar removal. Also no necropsy was performed. Exact time to onset is unknown. Other causes must be considered in this geriatric animal (20 years old ) with unknown health condition. Overall, considering application site involvement, a product relation is unassessable.