New incident report
Incident Report Number: 2017-2184
Registrant Reference Number: 2017KP128
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
Labrador Retriever
1
Female
15.5
55
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
>1 wk <=1 mo / > 1 sem < = 1 mois
Yes
Yes
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in May2016, post application, the dog exhibited a stroke, fell into the pool, was removed from the pool, and was resuscitated by the owner. The dog was examined by a veterinarian and was hospitalized overnight. It was unknown if any treatments or tests were performed. On an unknown date May2016, post onset of signs, the dog discharged from the hospital and to the care of the owner. Approximately 8 hours post discharge, the dog died. No necropsy was performed. 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 use of the product and not to report the death of the patient. No further information is expected. This case is closed. Note: Previous applications were well tolerated.
Death
Reported neurological sign and death are not expected after product application as inconsistent with product pharmaco toxicological profile. Dog died likely due to the stroke reported. Time for reporting is long (7 months) as the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. 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 previous applications were well tolerated by dog. Considering overall aspects, a product connection is deemed to be unlikely.