New incident report
Incident Report Number: 2017-3264
Registrant Reference Number: USA-BAYERBAH-2015-US0059325
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: FLORIDA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-151
Product Name: advantage II small cat
Other (specify)
Spot-on solutionYes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Cat / Chat
Unknown
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
>24 hrs <=3 days / >24 h <=3 jours
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 12-Nov-2015, a feline, of unknown signalment and condition, with no know concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On 14-Nov-2015, the cat had diarrhea and died. No known medical intervention or necropsy was performed. No further information is expected. This case is closed.
Death
N - Unlikely Diarrhoea is not anticipated with appropriate topical product use. Oral ingestion of product was not observed. Even with oral product exposure signs would not be expected. 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 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Time to onset is bit long. Even though some information is missing (medical history and necropsy details) other etiologies should be considered first. Overall, considering known safety profile of the product a product relation is considered to be unlikely.