New incident report
Incident Report Number: 2017-4145
Registrant Reference Number: USA-BAYERBAH-2017-US0031103
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: CALIFORNIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-152
Product Name: Advantage II Large Cat
Other (specify)
Spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Unknown
1
Unknown
Unknown
8.165
kg
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 2016, an 18 pound, feline, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On an unknown date post application, in approximately 2016, the feline passed away. No necropsy conducted. The intent of the call was to discuss the product on another animal and not to report this death. This case is closed. No additional information expected.
Death
N - Unlikely The intent of the call was to discuss the product use on another animal and not to report this death. Nevertheless death is inconsistent with pharmaco-toxicological product profile and experience. No signs of anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by cats 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 (approximately more than 6 months). Even though some information regarding (health status, animal age, time to onset and necropsy results etc.) is not available, considering the known safety profile of the product, a product involvement is deemed to be unlikely.