New incident report
Incident Report Number: 2017-4011
Registrant Reference Number: USA-BAYERBAH-2017-US0019262
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 JERSEY
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-144
Product Name: K9advantixII extra large dog
Other (specify)
spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Afghan Hound
1
Male
12.5
Unknown
Skin
Unknown / Inconnu
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 01-May-2016, a 12.5 year old, intact, male, Afghan Hound canine, of unknown weight, in unknown 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 01-Jun-2016, the dog died. 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 the product and not to report the death of the patient. No further information is expected. This case is closed. Note: Previous applications were well tolerated.
Death
N - Unlikely Reported death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Very long time for reporting (approximately 10 months) as the intent of the phone call to Bayer was to discuss the use of the product and not to report the death of the patient. Moreover, previous applications were well tolerated. Other etiologies are more probable in this geriatric dog. Overall, considering long time to onset (>1 month), a product connection is deemed to be unlikely.