New incident report
Incident Report Number: 2017-6536
Registrant Reference Number: USA-BAYERBAH-2017-US0036897
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: PENNSYLVANIA
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
Other
Cat / Chat
Unknown
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
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 cat of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. On an unspecified date in approximately 2017, post application, the cat 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 phone call was to inquire about product expiration date and not to report the death in this event. No further information is expected. This case is closed.
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 owner called to inquire about product expiration date and not to report the death in this event. Even though some information is not available (health status, medical history, time to onset and necropsy results), considering known safety profile of product, a product relation is deemed to be unlikely.