New incident report
Incident Report Number: 2017-4480
Registrant Reference Number: USA-BAYERBAH-2017-US0030272
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: NEW HAMPSHIRE
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
Animal's Owner
Dog / Chien
Dobermann
1
Female
Unknown
40.823
kg
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Other / Autre
specify Unknown
(eg. description of the frequency and severity of the symptoms
On an unknown date in 2016, an unknown age, 90 pound, female, Dobermann dog, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Permethrin-Pyriproxyfen) via the topical route by the animal owner. On an unknown date in 2016, the dog died. Is is unknown if the dog was examined by a veterinarian or if a necropsy was performed. Due to the sensitive nature, all of the information was not obtained. Further attempts will not be made to obtain the information. The owner was calling about the product use on a different dog. 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. Time for reporting is too long (6 months and more) as the intent of the phone call to Bayer was not to report this event but to inquire on product use for a different dog and not to report the death of the patient. Other etiologies more probable. Finally, though low level of information (age, medical history, necropsy details and time to onset are unknown), considering the known product profile, a product connection is deemed to be unlikely.