New incident report
Incident Report Number: 2014-0372
Registrant Reference Number: 2014CK052
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. 11556-142
Product Name: K9 Advantix II(medium dog)
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
schnauzer (miniature)
1
Male
12
20
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
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 approximately Jun2013 the dog was diagnosed with liver failure and was prescribed unknown medications. The dog later began having seizures. The dog was examined at an emergency veterinary clinic and treated for the seizures with an unknown medication.On an unknown date in approximately Aug2013 the dog died at home. No necropsy was performed.
Death
Liver failures and death not expected after product application, as inconsistent with pharmaco-toxicological product profile. It is known that, at recommended dosage, none of active ingredients in the product have the potential to provoke seizures in dogs neither alone nor in combination. Only mild neurological signs, e.g. tremors or ataxia, may occur even after licking. Other causes are more probable, i.e. the patient was diagnosed with liver failure and thereafter had developed seizures. Inconsistent time to onset of liver failure and seizures (approximately 2 months). The dog died 2 months later and had not received further product applications. No necropsy was performed. Furthermore, the owner contacted Bayer Animal Health 3 months after the event to seek advice on how to control an active flea infestation and not to report the death of the patient. Previous applications well tolerated. Considering all aspects, a product connection is deemed to be unlikely.