New incident report
Incident Report Number: 2021-3619
Registrant Reference Number: USA-BAYERBAH-2021-US0026921 (Report 708878)
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 large dog
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Crossbred (Cane Corso x)
1
Female
5
Unknown
Skin
>8 hrs <= 24 hrs / >8 h <= 24 h
>8 hrs <=24 hrs / > 8 h < = 24 h
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Approximately 1 day post collar application, the canine exhibited anorexia. The collar was removed. Approximately 2 days post collar application, the anorexia improved. Approximately 3 days post collar application, the canine died. The canine was not examined nor was there a necropsy examination preformed. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable Reported anorexia is an unspecific and may have numerous other causes. Sign may occur initially after collar administration. 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 sign 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 sign. 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. No veterinarian was consulted. Animal died 3 days after collar removal. Other causes must be considered. Time to onset short. Considering the product profile, product involvement is deemed unlikely for the death of the animal, however due to limited information (health status and necropsy report), case is considered unassessable.