New incident report
Incident Report Number: 2018-2724
Registrant Reference Number: USA-BAYERBAH-2018-US0031757 (Report 497318)
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: ALABAMA
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
Unknown
1
Unknown
Unknown
Unknown
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
It is unknown if the product was used correctly. On approximately Jun-2018, the dog died. No necropsy was performed. The reason for the initial call was to discuss the product with another pet and not to report the death in this event. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. No further information is expected. This case is closed.
Death
N - Unlikely 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. Moreover, the reason for the initial call was to discuss the product with another pet and not to report the death in this event. Time to onset is long. Even though some information is not available (e.g. Health status and necropsy report), considering known product profile a product relation is unlikely.