New incident report
Incident Report Number: 2016-4202
Registrant Reference Number: 2016KP106
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
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-143
Product Name: k9 advantix II large dog
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Australian Cattle Dog
1
Female
1
33
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>2 hrs <=8 hrs / > 2 h < = 8 h
System
Unknown / Inconnu
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Approximately 3 hours post application, the dog was lethargic. The owner bathed the dog with a dawn dish soap. On 22 Apr 2016, the dog was inappetant. The canine was examined by the attending veterinarian. A complete blood count showed a severely low platelet count of 33 K/uL (thrombocytopenia). No treatments were performed. Approximately 8 hours after the veterinary visit, the canine had heavy breathing (dyspnea). On 23 Apr 2016, the signs continued and the canine was examined by the attending veterinarian. A complete blood count showed the platelet count had decreased further to 13 K/uL. The canine was hospitalized and treated with an unknown dose of vitamin K via an unknown route by the attending veterinarian. The canine died at the hospital. No necropsy was performed. No further information is expected. This case is closed.
Death
Lethargy and inappetence are unspecific sign and likely due to underlying condition, revealed later on. Thrombocytopenia and reported dyspnoea are not expected after product application as they are inconsistent with pharmaco-toxicological product profile. Death is not expected either an dlikely consequence of underlying condition. Time to onset for death is over one day, therefore allergic/anaphylactic reaction can be ruled out. Other causes should be considered, e.g. poisoning with anti-vitamin K, as suspected by the vet. Even though no necropsy was performed and time to onset is consistent for initially reported signs, considering all other aspects (unexpected signs/death, strong suspicion of poisoning), a product connection is unassessable.