New incident report
Incident Report Number: 2016-4196
Registrant Reference Number: 2016KP100
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. 11556-128
Product Name: k9 advantix II small dog
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Yorkshire Terrier
1
Unknown
14.5
4
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
<=30 min / <=30 min
System
>24 hrs <=3 days / >24 h <=3 jours
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Immediately post administration, the canine exhibited mild lethargy. 1 day post administration in 2014, the lethargy resolved. On an unknown date post administration in 2014, the canine died. It is unknown if the canine 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 phone call was to discuss the product safety for her new dog and not to report the death of the patient.
Death
Though time to onset is short, lethargy is very unspecific sign and may have numerous other causes. However, death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Very low level of information (time to onset for death unknown - necropsy not available) and long time for reporting (approximately 2 years) as the intent of the phone call to Bayer was to discuss the product safety for her new dog and not to report the death of the patient. 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. Other etiologies are more probable. Even though time to onset for death is unknown, considering overall aspects, product connection deemed to be unlikely.