New incident report
Incident Report Number: 2017-6931
Registrant Reference Number: USA-BAYERBAH-2017-US0058801 (Report 445061)
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. 11556-151
Product Name: Advantage II Small 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 unknown date in 2017, a feline, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On an unknown date post product application, in 2017, the feline died. It is unknown if medical intervention was sought. 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 phone call was to discuss product use and not to report the death of this feline. No further information is expected. The case is closed.
Death
N - Unlikely Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. No signs of allergic/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. Moreover, the owner called to discuss product use and not to report the death of this feline. Even though some information is not available (time to onset and necropsy results), considering known safety profile of product, a product relation is deemed to be unlikely.