New incident report
Incident Report Number: 2017-6941
Registrant Reference Number: USA-BAYERBAH-2017-US0060848 (Report 446598)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: GEORGIA
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
Animal's Owner
Cat / Chat
Ragdoll
1
Male
10
3.629
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 01-Sep-2017, a 10 year old, 8 pound, neutered, male, Ragdoll cat, in unknown condition, with a concomitant medical condition of fleas, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. On 18-Sep-2017, the cat died. No known necropsy was performed. No further information expected. This case is closed. The initial call to Bayer Animal Health was to inquiry about a current flea infestation and not to report the death of this animal.
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. Moreover, the initial call was to inquire about a current flea infestation and not to report the death of this geriatric cat. Time to onset is not suggestive of product relation. Even though no necropsy was performed sufficient information exists to rule out product relation completely. Overall, a product relation is consider as unlikely.