New incident report
Incident Report Number: 2020-2841
Registrant Reference Number: USA-BAYERBAH-2020-US0031774 (Report 648056)
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: WASHINGTON
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Small Dog
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Crossbred (Yorkshire Terrier x Poodle (Miniature))
1
Female
12
5.897
kg
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
On an unspecified date in Feb 2020, the dog exhibited unspecified pain. On an unspecified date, one day post onset of pain, in Feb 2020, the dog died. No necropsy was performed. The intent of the call was to inquire about product use in general and not to report this event. No more information is expected and this case is closed.
Death
N - Unlikely Pain is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Death is not expected either. 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. The reporter called Bayer not to report this event but to raise questions concerning the product (e.g. mode of action) and apparently did not see a relation between product use and the sign reported. Time to onset is long. Considering all aspects, a product involvement is unlikely.