New incident report
Incident Report Number: 2017-6925
Registrant Reference Number: USA-BAYERBAH-2017-US0057967 (Report 444580)
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. 11556-127
Product Name: Advantage II Extra Large Dog
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Golden Retriever
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 approximately 01-Jan-2015, a Retriever - Golden dog with unknown signalment, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Extra Large Dog (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. On an unspecified date in 2017 the dog passed away. 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 call was to inquire about using the product on another pet and not to report the death in this event. No further information is expected. This case is closed.
Death
N - Unlikely Death is not expected after product administration as inconsistent with pharmaco-toxicological product profile and experience. 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. The reason for the initial call was to inquire about using the product on another pet and not to report the death in this event. Time to onset is not suggestive of product relation. Even though some information is not available (e.g. medical history and necropsy report) sufficient information exists to rule out product relation completely. Overall, a product relation is consider as unlikely.