New incident report
Incident Report Number: 2017-3270
Registrant Reference Number: USA-BAYERBAH-2015-US0062426
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: PENNSYLVANIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Advantage II unspecified size
Other (specify)
Spot-onYes
Unknown
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 in approximately 2013, a canine, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II (dog-unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date post application, in 2013, the dog died. No necropsy was performed. The reporting party did not contact Bayer Animal Health to report the death of the animal but to inquire about additional product applications. No more information is expected. Case is closed.
Death
N - Unlikely The information regarding the death of the dog was casually provided during an inquiry as the reporting party did not contact Bayer Animal Health to report the death of the animal but to inquire about additional product applications. Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergic/anaphylactic reaction reported in close proximity of product application. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 20-fold overdosage tolerated by dogs without showing any side effect. Moreover in case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. Overall, even though, the level of information is very low, considering known safety profile of the product, product relation is unlikely.