New incident report
Incident Report Number: 2016-4207
Registrant Reference Number: 2016KP111
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: k9 advantix II unknown
Liquid
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Other
Dog / Chien
Unknown
1
Unknown
Unknown
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in 2014, the dog was administered an unknown dose of oral afoxolaner. On an unspecified date post application, in approximately 2014, the dog died. 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 phone communication was to discuss product use on another dog and not to report the death of the patient. No further information is expected. Case is closed.
Death
Death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Long time for reporting is long (2 years) and time to onset unlikely, as would have been reported in close proximity. Other causes are more probable in this dog. Though absence of necropsy, considering all aspects, product connection deemed to be unlikely. not provided as intent of the phone call to Bayer was to discuss product use on another dog and not to report the death of the patient. Though no time to onset reported, no signs of allergy/anaphylactic reaction reported. Even though time to onset unknown, occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Other causes are more probable in this dog. Though absence of necropsy, considering all aspects, product connection deemed to be unlikely.