New incident report
Incident Report Number: 2014-5662
Registrant Reference Number: 2014CK433
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Rd
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
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
Animal's Owner
Dog / Chien
cocker spaniel
1
Female
Unknown
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>1 mo <=2 mos / > 1 mois < = 2 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in Jun2013 the canine was diagnosed with mammary cancer and died. No known treatments were performed and it was unknown if a necropsy examination was performed.Due to the sensitive nature of the communication, specific event details were not obtained, nor will such be sought. The reason for the initial call was to discuss the efficacy of the product on her current dogs and not to report the death of this patient. No further information is expected. This case is closed.
Death
Mammary cancer is not expected in dog after product use, as inconsistent with pharmaco-toxicological product profile. Very low level of information (age, weight, product details, medical history, time to onset unknown and necropsy unknown) as the reason for the initial call was to discuss the efficacy of the product on her current dogs and not to report the death of this patient. As reported, the dog was died due to the underlying disease (mammary cancer) thus evidence of the progression of the dog's medical conditions. 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. Considering all aspects, product connection deemed to be unlikely