New incident report
Incident Report Number: 2017-3261
Registrant Reference Number: USA-BAYERBAH-2015-US0057095
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
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-152
Product Name: Advantage II Large Cat
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Cat / Chat
Unknown
1
Male
12
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Due to the sensitive nature of the communication, specific relevant details were not obtained nor will they be sought. On an unknown date in 2015, a 12 year old, neutered, male, Unknown Breed (Feline) feline, in good condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On an unknown date in Jun2015, the cat died due to an unknown neoplasia. No necropsy was performed. No more information is expected and the case is closed.
Death
N - Unlikely The information regarding the death of the cat was casually provided during an inquiry as the reason for the initial call to Bayer Animal Health was to discuss the use of this product on another animal and not to report this event. Nevertheless neoplasia and death are inconsistent with pharmacotoxicological product profile and experience. 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 cause of death was a neoplasia. The product has no carcinogen potential. Cat was geriatric. Though some information is missing (time to onset and necropsy details), considering known safety profile of the product, a product relation can be excluded completely and relation considered as unlikely.