New incident report
Incident Report Number: 2017-7493
Registrant Reference Number: USA-BAYERBAH-2017-US0068851 (Report 454382)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Advantage II pipette size unknown
Other (specify)
Spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Unknown
1
Unknown
Unknown
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in approximately 2015, a dog, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II (dog-unspecified) (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. On an unspecified date in approximately 2015, post application, the dog died. No known 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 mode of action of the product and not to report the death in this event. No further information is expected; the case is closed.
Death
N - Unlikely Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Moreover, the reason for the initial phone call was to discuss the mode of action of the product and not to report the death in this event. In case of suspected product involvement case would have been reported in close proximity and not after long time (almost after 2 years). Even though some information is not available (animal details, necropsy report and time to onset), sufficient information exists to rule out product relation completely. Overall, a product relation is considered as unlikely.