New incident report
Incident Report Number: 2017-3262
Registrant Reference Number: USA-BAYERBAH-2015-US0057810
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. 11556-151
Product Name: Advantage II Small Cat
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Cat / Chat
Unknown
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in approxiamtely 2013, an Unknown Breed feline, of unknown signalment and in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date in 2013 the cat died of cancer (neoplasia). A necropsy was not performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such besought. The reason for the initial call was to discuss the use of our product for an active flea infestation on another animal, and not to report the death of the patient. No further information expected. Case is closed.
Death
N - Unlikely Neoplasia and death are not expected after appropriate product application as inconsistent with pharmacotoxicological product profile. 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 neoplasia. The product has no carcinogen potential. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. Moreover, the reason for the initial call was to discuss the use of our product for an active flea infestation on another animal and not to report the death of the patient. Overall, even though no necropsy was performed considering known safety profile of the product, product relation is unlikely