New incident report
Incident Report Number: 2017-6945
Registrant Reference Number: USA-BAYERBAH-2017-US0061008 (Report 447265)
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: CALIFORNIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-152
Product Name: Advantage II Large Cat
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Cat / Chat
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 2017, a 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 unspecified date post application, in approximately 2017, the cat died. No known necropsy was performed. No more information is expected; this case is closed. Note from LDSM: The reporting party contacted Bayer Animal Health to inquire about expiration dates of the product and not report the death of the animal.
Death
N - Unlikely Reported death is inconsistent with pharmaco-toxicological product profile and experience. 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. Moreover, the reporting party contacted Bayer Animal Health to inquire about expiration dates of the product and not report the death of the animal. Even though some information is not available (time to onset and necropsy results), considering serious outcome and known safety profile of product, a product relation is deemed to be unlikely.