New incident report
Incident Report Number: 2013-6278
Registrant Reference Number: 2013CK026
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. 11556-130
Product Name: Advantage II Extra Large Dog
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Cross Breed
1
Female
11
56
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Persisted until death
Unknown
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
An unspecified amount of time after application, the patient was diagnosed with pancreatitis. It is unknown whether any treatments were performed or not. On approximately 01-Feb-2013, the owner applied another dose of the product. An unspecified amount of time later, the patient was diagnosed with liver disease and died. It is not known whether or not a necropsy was performed.
Death
The intent of the phone call to Bayer was to inquire about another product and not to report the death of this patient. No further information is expected.The information regarding the death of the dog was casually provided during an inquiry. Reporting of occurrence over one year after product application, thus occurrence of fatal outcome probably not within close time of product application. Time after previous exposure to onset of pancreatitis or liver disorder unknown. Both pancreatitis and liver disorder are not expected, as inconsistent with pharmaco-toxicological product profile. Death not expected either after product application, as inconsistent with pharmaco-toxicological product profile. Product has wide margin of safety. Oral LD50 in rat 642 mg / kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Other causes due to underlying hepathic (or pancreatic) disease and/or old age of dog more likely cause of death. Therefore, a product relation is considered unlikely.