New incident report
Incident Report Number: 2020-0449
Registrant Reference Number: USA-BAYERBAH-2020-US0003559 (Report 619462)
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: ALABAMA
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
Great Dane
1
Male
Unknown
Unknown
Skin
>6 mos <=1 yr / > 6 mois < = 1 an
>6 mos / > 6 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 01-Sep-2017 the dog exhibited a fractured leg and died. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The intent of the call was to ask about product use in general, and not to report the event. No further information is expected. This case is closed.
Death
N - Unlikely Reported fractured leg and death are 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Time to onset is considerably long. Other causes (e.g. severe trauma) seem more probable although not described. Additionally, the intent of the call was to inquire about product use in general, and not to report this event. Considering all aspects, sufficient information exists to conclude that the product did not cause the event. Finally, product relation is considered as unlikely.