New incident report
Incident Report Number: 2018-0479
Registrant Reference Number: USA-BAYERBAH-2017-US0078989 (Report 465131)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: TENNESSEE
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto large dog
Other (specify)
COLLARYes
Other Units: Collar
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Pit Bull
1
Female
10
27.216
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in Dec 2017, approximately 2 months post application, the dog died. No known necropsy was performed. Due to the sensitive nature of information, specific relevant event details were not obtained so as not to further strain the relationship between the reporting party and Bayer Animal Health. No further information is expected. This case is closed. Follow up received on 02nd Jan 2018: On 02-Dec-2017, a 10 year old, approximately 60 pound, female, Pit Bull canine, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Large Dog Collar (Flumethrin-Imidacloprid) placed around the neck by the owner. On 24 Dec2017 the dog died. No necropsy was preformed. No further information is expected. This case is closed.
Death
N - Unlikely 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. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset is also not suggestive of product relation. Finally, sufficient information exists to rule out product relation completely. Finally, a product relation is considered as unlikely.