New incident report
Incident Report Number: 2015-4036
Registrant Reference Number: 2015KP0063
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Blvd. East
City: Mississauga
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. Unknown
Product Name: Advantage (unknown size)
Liquid
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Other
Cat / Chat
unknown
1
Female
20
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>3 days <=1 wk / >3 jours <=1 sem
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Immediately post application the cat exhibited hypersalivation. The clinical sign resolved approximately 1 hour later. At an unspecifed time post application in approximately 2013 the cat died. No necropsy was performed. No more information is expected. Case is closed.
Death
Hypersalivation after suspected ingestion or licking of product. Sign is consistent with distaste reaction. Time to onset is short for hypersalivation. Death is inconsistent with pharmaco-toxicological product profile and experience. No signs of allergic/anaphylactic reaction reported. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold over dosage tolerated by cats without showing any side effect. Cat is geriatric, age of the cat is 20 years, hence other etiologies are more probable. Moreover, the reason for the initial call was to inquire about the use of the product on another animal and not to report this event. Even some information missing (no necropsy, exact time to onset between product application and death of the cat) considering all aspects, product relation is unlikely.