New incident report
Incident Report Number: 2017-4916
Registrant Reference Number: USA-BAYERBAH-2017-US0040036
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
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-144
Product Name: K9 advantix II extra large dog
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Unknown
1
Male
Unknown
Unknown
Skin
Unknown / Inconnu
>6 mos / > 6 mois
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 05-Jun-2015, a male, canine, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On approximately 05-Jul-2017, the dog died of unknown cause. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss the use of K9 Advantix II on her current pet and not to report the death of the patient. No further information is expected. This case is closed.
Death
N - Unlikely Death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Other causes are more likely. Moreover the intent of the phone call to discuss the use of K9 Advantix II on her current pet and not to report the death of the patient. Finally, even though no known necropsy was performed, overall, considering the known product profile, and long time to onset (2 years), sufficient information exists to conclude that the product did not cause the event and a product connection is deemed to be unlikely.