New incident report
Incident Report Number: 2017-8030
Registrant Reference Number: USA-BAYERBAH-2017-US0075730
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: VIRGINIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-151
Product Name: Advantage II small cat
Other (specify)
Spot-onYes
Other Units: ml
Site: Animal / Usage sur un animal domestique
No
Animal's Owner
Cat / Chat
Unknown
1
Female
Unknown
5.216
kg
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in 2015, following administration, the cat died. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss the use of Advantage II to treat fleas in owners current cat and not to report the death of the patient. No further information is expected. This case is closed.
Death
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. However in case of suspected product involvement, adverse event would have been reported in close proximity and not long time (2 years) after. The reason for the initial call was to discuss the use of product to treat fleas in owners current cat and not to report the death of the patient. Even though some information is not available (animal details, health status, time to onset and necropsy report), sufficient information exists to rule out product relation completely. Overall, a product relation is consider as unlikely.