New incident report
Incident Report Number: 2016-2712
Registrant Reference Number: 2016KP030
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: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-125
Product Name: advantage II medium dog
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Crossbreed
1
Female
13
13.5
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
>1 wk <=1 mo / > 1 sem < = 1 mois
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
An unknown time post administration in 2013, the canine died. It is unknown if the canine was euthanized 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 phone call was to discuss an issue with a Seresto collar and not to report the death of the patient. No further information is expected. This case is closed.
Death
Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergic/anaphylactic reaction reported in close proximity of product application. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (3 years). Further, the owner did not believe in product involvement either as reason for the initial call was to discuss an issue of other product and not to report the death of the patient. Moreover the reported animal was geriatric which may be the likely cause for the death of an animal. Considering these aspects, in spite of the limited information (time to onset, absence of necropsy results and medical history of the dog), considering known safety profile of the product, product relation is unlikely.