New incident report
Incident Report Number: 2018-2077
Registrant Reference Number: USA-BAYERBAH-2018-US0016307 (Report 481524)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississauga
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: UNITED STATES
Prov / State: PENNSYLVANIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Advantage II pipette size unknown
Other (specify)
Spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Miniature Poodle
1
Male
Female
9
Unknown
Skin
Unknown / Inconnu
Unknown / Inconnu
System
Unknown / Inconnu
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On a unknown date post application, in 2018, the dog was administered an unknown anesthesia and had an unspecified surgical procedure performed by the attending veterinarian. On an unknown date post application, in 2018, 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 communication was to discuss use of the product and not to report the death in this event. 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. Moreover owner does not think of product involvement as the reason for the initial phone call was to discuss use of the product and not to report the death in this event. Even though some details are not available (animal details, time to onset and necropsy report), considering known safety profile of the product and available information, a product relation is unlikely.