New incident report
Incident Report Number: 2018-2781
Registrant Reference Number: USA-BAYERBAH-2018-US0029888 (Report 495348)
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: GEORGIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-127
Product Name: advantageII large dog
Other (specify)
spot onYes
Units: mL
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
unknown
1
Unknown
Unknown
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date post application in 2016, the dog died. It is not known if veterinary evaluation or treatment occurred and 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 intent of the call was not to report this event, but to inquire about the expiration date of the product. No further information is expected. This case is closed.
Death
N - Unlikely Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. Product has wide margin of safety. The oral LD50 in rat is 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. The intent of the call was not to report this event, but to inquire about the expiration date of the product. In case of suspected product involvement adverse event would have been reported in close proximity and long time after (more than one year). Even though some information is not available ( animal details, time to onset and necropsy), sufficient information exists to rule out product relation completely. Overall, a product relation consider as unlikely.