New incident report
Incident Report Number: 2021-3138
Registrant Reference Number: USA-BAYERBAH-2021-US0020833 (Report 701944)
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
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar unknown
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Cocker Spaniel
1
Unknown
7
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Yes
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in 2021, the canine had to have unspecified surgery on the neck for unspecified reason. On an unknown date in 2021, the canine died from cancer. No necropsy was performed. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable Reported serious sign of cancer and death are 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. 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. Outcome was the consequence of alternative causes (cancer) and thus, sufficient information exists to rule out product involvement. However, considering some information is missing (such as unknown health status, time to onset and necropsy details are unknown), a relation to case is unassessable.