New incident report
Incident Report Number: 2017-4937
Registrant Reference Number: USA-BAYERBAH-2017-US0042210
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: ILLINOIS
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-144
Product Name: K9advantix 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
Unknown
Unknown
Unknown
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 unspecified date in approximately 2012, a dog, 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) via the topical route by the animal owner. On an unspecified date in approximately 2012, post application, the dog died. The dog was not examined by a veterinarian and no known 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 phone call was to discuss the expiration date in regards to use on a different pet and not to report the death in this event. No further information is expected. This case is closed.
Death
N - Unlikely Death not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Very low level of information (age, medical history and time to onset unknown - necropsy not available) as the intent of the phone call to Bayer was to discuss the expiration date in regards to use on a different pet, and not to report the death of the patient. Other etiologies more probable. No signs of allergy/anaphylactic reaction reported. Even though time to onset unknown, occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity and not 5 years later. Considering all aspects, product connection deemed to be unlikely.