New incident report
Incident Report Number: 2017-2174
Registrant Reference Number: 2017KP118
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: 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
Unknown
1
Male
12
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date post application, in approximately 2016, the cat died of unknown causes. No necropsy was performed. The reporting party did not contact Bayer Animal Health to report the death of the animal but to inquire about using the product on her current feline. No further information is expected. This case is closed. Note: Previous exposure was well tolerated by animal.
Death
Reported death is inconsistent with pharmacotoxicological 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. Involve animal was geriatric which may have further contribute to death of the animal. Previous exposure of product was well tolerated by animal. Moreover, the reporting party did not contact Bayer Animal Health to report the death of the animal but to inquire about using the product on her current feline. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. 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.