New incident report
Incident Report Number: 2017-0544
Registrant Reference Number: 2017KP052
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
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Unknown
1
Unknown
Unknown
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date post administration in Aug 2016, the canine died. It is unknown if the dog was euthanized or if a necropsy was performed. No further information is expected. This case is closed. 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 a flea issue with her new dog and not to report the death of the patient.
Death
Death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Low level of information (age, time to onset unknown - necropsy not available) as the intent of the phone call to Bayer was to discuss a flea issue with her new dog 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. Moreover time taken for reporting is long (> 2 months) as reporting of this adverse event likely done during the report of the linked recent adverse event in another dog with another product. Considering all aspects, product connection is unlikely.