New incident report
Incident Report Number: 2017-4950
Registrant Reference Number: USA-BAYERBAH-2017-US0045449
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: CALIFORNIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-151
Product Name: Advantage II small cat
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Cat / Chat
Unknown
1
Unknown
Unknown
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 post application, in 2015, the feline died. No known necropsy was performed.
Death
The initial call to Bayer Animal Health was to inquiry about product expiration date and not to report the death of the feline. Due to the sensitive nature of the communication, additional details will not be sought. N-Unlikely: 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. The reason for the initial call was to inquire about product expiration date and not to report the death of the feline. In case of suspected product involvement adverse event would have been reported in close proximity and long time after (almost after 2 years). Finally, even though some information is not available, (animal details, health condition, time to onset and necropsy details), Sufficient information exists to rule out product relation completely. Overall, a product relation consider as unlikely.