New incident report
Incident Report Number: 2017-6540
Registrant Reference Number: USA-BAYERBAH-2017-US0037191
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: PENNSYLVANIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar small dog
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Pomeranian
1
Female
7
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in 2016, a 7 year old, female, Pomeranian canine, of unknown weight, in unknown condition, with no known concomitant medical conditions, had 1 Seresto Small Dog collar (Flumethrin-Imidacloprid) placed around the neck by the owner. On unknown date in 2016, post applicaitoin, the canine was anorexic and was examined by a veterinarian. It was unknown if treatments were performed. On unknown date in Nov2016, post application, the canine died and 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 reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. No further information is expected, this case is closed.
Death
N - Unlikely Anorexia is an unspecific sign and may have numerous other causes. Further reported 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 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, owner does not believe in product connection as the reason for call to Bayer was to discuss the use of the product and not to report the death of the patient. Finally, though some information missing (state of health, time to onset and necropsy details), considering that time for reporting is long and known safety product profile, a product connection is deemed to be unlikely.