New incident report
Incident Report Number: 2017-4920
Registrant Reference Number: USA-BAYERBAH-2017-US0040613
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. Unknown
Product Name: K9 Advantix II pipette size unknown
Other (specify)
Spot-onYes
Unknown
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
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date approximately 2016, a canine, of unknown signalment, in unknown condition, with no known concomitant medical conditions, was administered one tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner. On an unknown date in approximately 2016, the canine died. No known necropsy was performed. No further information is expected. Case is closed. Note: The reason for the initial phone call was to discuss the use of the product and not to report the death of the patient.
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) 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. Other etiologies more probable. Even though time to onset is unknown, occurrence of sign within window of allergic/anaphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Though very low level of information (age, medical history and time to onset unknown - necropsy not available), considering known product safety profile, a product connection is deemed to be unlikely.