New incident report
Incident Report Number: 2017-4033
Registrant Reference Number: USA-BAYERBAH-2017-US0012465
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: LOUISIANA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: advantage II pipette size unknown
Other (specify)
Spot onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Cat / Chat
Himalayan
1
Male
16
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 2016, a 16 year old, neutered, male, Himalayan feline, of unknown weight, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date in 2016, post application, the cat died at home. A necropsy was not 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 phone call was to discuss the use of the product and not to report the death of the patient. No further information is expected. Case is closed. Note: Previous exposure was well tolerated by animal.
Death
N - Unlikely Death is inconsistent with pharmaco-toxicological product profile and experience. 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. Involved animal is geriatric. Previous exposure was well tolerated by animal. Moreover, the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. Even though some information (time to onset and necropsy results) missing, considering known product safety profile and unexpected fatal outcome, a product involvement is deemed to be unlikely.