New incident report
Incident Report Number: 2017-2164
Registrant Reference Number: 2017KP108
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. Unknown
Product Name: advantage II unknown
Liquid
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Other
Cat / Chat
Unknown
1
Female
16
Unknown
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 an unknown date post application, in 2014, the feline died. It was unknown if the feline was examined by a veterinarian and no 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 phone call was to discuss the use of the product and not to report the death of the patient. No further information expected. This case is closed. Note : previous exposure was well tolerated by animal.
Death
Death not expected after product application, as inconsistent with pharmaco-toxicological 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. Animal involved in this case was geriatric, and thus numerous other health problems have to be considered as cause of death. Moreover, previous exposure was well tolerated by the animal. In case of suspected product involvement event would have been reported in close proximity and not long time (almost 3 years) after. The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. Even though some information is not available (animal details, health status, and necropsy report) sufficient information exists to ruled out product relation completely. Overall, product involvement is considered unlikely.