New incident report
Incident Report Number: 2017-0672
Registrant Reference Number: 2017KP028
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: UNKNOWN
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-151
Product Name: advantage II small cat
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Other
Cat / Chat
Unknown
1
Male
22
4
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
>1 wk <=1 mo / > 1 sem < = 1 mois
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 28-Oct-2016, the cat died due to unknown causes. No known 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 on her current pet and not to report the death of the patient. No further information is expected. This case is closed. Follow-up received on 1st Dec 2016: On an unknown date in 2016, a 22 year old, 4 pound, neutered, male, Unknown Breed feline, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid- Pyriproxyfen) topically by the owner.
Death
Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergic/anaphylactic reaction reported in close proximity of product application. 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. The information regarding the death of the cat was casually provided during an inquiry as the reporting party did not contact Bayer Animal Health to report the death of the animal but to discuss the use of Advantage II on her current pet. The cat in this case was geriatric and likely have died of old age. Finally, even though some information (e.g. time to onset, health status and necropsy results) is not available, considering known product safety profile a product relation is unlikely.