New incident report
Incident Report Number: 2017-6501
Registrant Reference Number: USA-BAYERBAH-2017-US0035774
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
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: K9 advantix II pipette size unknown
Other (specify)
spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Other
Dog / Chien
Boxer (German Boxer)
1
Female
12
36.287
kg
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Persisted until death
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
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 product efficacy and not to report the death of the patient. On an unknown date in approximately 2015, a 12 year old, 80 pound, female, Boxer canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On an unknown date post application, in approximately 2015, the canine was diagnosed with an unspecified oral cancer. The product was applied approximately every 4 weeks, with the most recent dose on an unknown date in approximately 2016. On an unknown date post application, in approximately 2016, the canine died. No known necropsy was performed. No further information expected. Case closed.
Death
N - Unlikely Reported death not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Very low level of information (time to onset unknown - necropsy not available) as the intent of the phone call to Bayer was to discuss the product efficacy and not to report the death of the patient. Dog likely died due to diagnosed oral cancer. 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. Considering all aspects, product connection deemed to be unlikely.