New incident report
Incident Report Number: 2017-0677
Registrant Reference Number: 2017KP018
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. 11556-130
Product Name: advantage II extra large dog
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Labrador Retriever
1
Unknown
Unknown
109
lbs
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 Apr2016, the canine died. It is unknown if the canine was examined by a veterinarian, euthanized, or if a 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 call was to discuss a current flea issue with her other dogs and not to report the death of the patient. No further information is expected. This case is closed.
Death
The information regarding the death of the dog was casually provided during an inquiry. Death is inconsistent with pharmaco-toxicological product profile and experience. No signs of allergic/anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold overdosage tolerated by dog without showing any side effect. Moreover, the caller contacted Bayer Animal Health to discuss a current flea issue with her other dogs and not to report the death of the patient. Finally, even though some information (e.g. Animal health status, medical history, time to onset, necropsy results and unknown whether animal was euthanised or died) is not available, sufficient information exists to rule out product relation completely. Overall, a product relation is considered as unlikely.