New incident report
Incident Report Number: 2013-4523
Registrant Reference Number: 2013AM202
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Rd
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-152
Product Name: Advantage II Large Cat
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
Domestic shorthair
1
Male
2
11.4
lbs
Skin
Unknown / Inconnu
>2 hrs <=8 hrs / > 2 h < = 8 h
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 15May2013, an approximately 2 year old, 11.4 pound, neutered, male, Domestic Shorthair, in fair condition, in fair condition, with a history of longstanding left ventricular with hypertrophy and dysfunction, chronic hepatitis, and chronic renal infarction, was administered one Rabies vaccine, one Distemper vaccine, one tablet of Nitenpyram, and 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) once topically by the attending vet. Approximately 3 hours later, the patient passed away. A necropsy is pending. Update: 2013-06-10. A necropsy was performed that showed the following result, which confirmed the concomitant medical conditions: hypertrophic cardiomyopathy, chronic hepatic congestion, and chronic renal infarction.
Death
ntended direct topical dermal exposure of the product to the cat. Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Product has wide margin of safety. Oral LD50 in rat 642 mg / kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Other products given concurrently that may have caused signs as well. A necropsy was performed that showed the following result, which confirmed the concomitant medical conditions: hypertrophic cardiomyopathy, chronic hepatic congestion, and chronic renal infarction. Although short onset time, death rather related to cat's underlying serious conditions. Thus, a product relation is considered unlikely.