New incident report
Incident Report Number: 2017-6544
Registrant Reference Number: USA-BAYERBAH-2017-US0038056
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: KANSAS
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-150
Product Name: Advantage II Kitten
Other (specify)
spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Domestic Shorthair
1
Male
0.249
1.59
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Persisted until death
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 16-Jun-2017, a 13 week old, 3.5 pound, neutered, male, Domestic Shorthair feline, in unknown condition, with a concomitant medical condition of fleas, was administered 1 tube of Advantage II Kitten (Imidacloprid-Pyriproxyfen) topically by the owner. On 25-Jun-2017, the feline exhibited lethargy and anorexia, so the owner bathed the cat in an unspecified soap. On 26-Jun-2017, the owner attempted to hand feed, but the cat exhibited lockjaw. On 27-Jun-2017, the feline died. No known necropsy was performed.
Death
N - Unlikely Reported systemic signs are unspecific and may have various other causes. Locked jaws are neither expected nor inline with products pharmaco-toxicological profile. 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 over dosage was tolerated by cats without showing any side effect. Time to onset is not suggestive of product relation either. Finally, even though some information is missing (state of health of animal and necropsy details), considering known safety product profile, a product relation is unlikely.