New incident report
Incident Report Number: 2016-4220
Registrant Reference Number: 2016KP124
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. 11556-144
Product Name: k9 advantix II extra large dog
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Flat-coated Retriever
1
Male
5
77
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
>1 wk <=1 mo / > 1 sem < = 1 mois
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in Jun2013 the dog had unspecified behavioral changes and was anorexic. The dog was examined by a veterinarian and started on an unknown treatment. The dog was also syringe fed by the owner. On an unspecified date in Jun2013 the dog died. No necropsy was performed. No more information expected. This case is closed. Note from LDSM: The communication was not to report this event, but to discuss the use of another product on a different animal. Note: Previous applications well tolerated.
Death
Reported behavioural disorder and anorexia are very unspecific signs and may have multiple potential causes in a dog. Reported death is not expected after product application, as it is inconsistent with pharmacotoxicological product profile. Death likely linked to an underlying condition, however no serious signs had been reported. Even though time to onset unknown, occurrence of death within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Moreover, previous applications were well tolerated. Other etiologies more probable. Actually, the intent of the call was not to report this event, but to discuss the use of another product on a different animal. Finally, though no necropsy was performed and time to onset is unknown, considering the known product profile, sufficient information exists to conclude that the product did not cause the event and a product connection is deemed to be unlikely.