New incident report
Incident Report Number: 2017-7479
Registrant Reference Number: USA-BAYERBAH-2017-US0066611 (Report 452110)
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: 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
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 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 call was to discuss product us on another pet and not to report the death in this event. No further information is expected. This case is closed.
Death
N - Unlikely The information regarding the death of the cat was casually provided during an inquiry. Nevertheless death is inconsistent with pharmaco-toxicological product profile and experience. 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. Finally, even though some information (e.g. time to onset) missing, considering known product profile and unexpected fatal outcome, a product involvement is deemed to be unlikely.