New incident report
Incident Report Number: 2017-4482
Registrant Reference Number: USA-BAYERBAH-2017-US0030782
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: MISSOURI
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Dog Collar unknown size
Other (specify)
CollarYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Border Collie
1
Unknown
Unknown
Unknown
Skin
>6 mos <=1 yr / > 6 mois < = 1 an
>6 mos / > 6 mois
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in Apr-2013, a Border Collie canine, of unknown signalment and condition, with the concomitant medical condition of a severe flea infestation, had 1 Seresto Dog (unspecified) (Flumethrin-Imidacloprid) placed around the neck by the owner. Approximately 8 months post administration in Dec2013, the collar became hard in texture and was removed. The dog had 1 new Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar was placed around the neck by the owner On an unknown date post administration in 2014, the canine died. It was unknown if the dog was examined by a veterinarian or if a necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss the product expectations for ticks and not to report the death of the patient.
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 dogs for an 8 months period without causing serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Moreover, the reason for the call was to discuss the product expectations for ticks and not to report the death of the patient. Even though some information is missing (time to onset, state of health, animal age and necropsy details), considering the known safety product profile sufficient information exists to conclude that the product did not cause the event and product involvement is unlikely.