New incident report
Incident Report Number: 2017-4053
Registrant Reference Number: USA-BAYERBAH-2017-US0015172
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
Other (specify)
Spot-onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Unknown
1
Unknown
15
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date in 2016, a 15 year old, canine, of unknown signalment, 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 an unknown date in Feb2016, post application, the canine died. It is unknown if the canine had been 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 contact by owner was to discuss expiration of the product and not to report the death in this event. No further information 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 exceptionally long (1 year and more) and the intent of the phone call to Bayer was to discuss expiration of the product and not to report the death in this event. Other etiologies more probable in this geriatric dog. 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. Finally, necropsy details are not available and time to onset is unknown, however, considering the known product profile, a product connection is deemed to be unlikely.