New incident report
Incident Report Number: 2013-4562
Registrant Reference Number: 2013AM180
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. 11556-116
Product Name: Advantage 9
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Cat / Chat
unknown
1
Unknown
20
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 unknown date in 2009, a 20 year old, feline of unknown signalment, in unknown condition, with a concomitant medical condition of renal failure, was administered 1 tube of Advantage 9 Topical Solution (Imidacloprid) once topically by the owner. On an unknown date in 2009 post product application the cat passed away due to renal failure. It is unknown if a necropsy was performed.
Death
The level of information is very low. Reporting of occurrence more than 3 years after product application, thus occurrence of fatal outcome probably not within close time of product application. Nevertheless renal failure and death are inconsistent with pharmaco-toxicological product profile and experience. 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. The cause of death of this geriatric cat was renal failure according to case description. The product has no nephrotoxic potential. Product was used on animal before without causing any signs. Finally, a product relation can be completely excluded.