New incident report
Incident Report Number: 2013-4535
Registrant Reference Number: 2013AM214
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. 11556-133
Product Name: K9 Advantix 20
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Jack Russell Terrier
1
Male
15.5
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 unknown date in 2011, a 15.5 year old, male, Terrier (Jack Russell) canine, in fair condition with congenital heart disease, was administered 1 tube of K9 Advantix 20 (500 mg Permethrin / 100 mg Imidacloprid) once topically by the owner. The product had not been applied to the dog for a few months prior to death. On an unknown date in 2012, the dog died. No necropsy examination was performed. The owner called regarding expiration date to use the product on another pet and not to report an adverse event.
Death
Death not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Reliability questionable due to very low level of information (time to onset unknown - necropsy not available). Other etiologies more probable, such as the concomitant heart condition. However, numerous other causes have to be considered in such a geriatric dog. 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.