New incident report
Incident Report Number: 2017-4472
Registrant Reference Number: USA-BAYERBAH-2017-US0028565
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: FLORIDA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-127
Product Name: advantage II 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
Unknown
Unknown
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in approximately 2017, a canine, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Large Dog (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date post application, in approximately 2017, the dog died. No known necropsy was performed. Limited information was obtained at the time of the communication. Further attempts to gather additional information will not be made. The reporting party contacted Bayer Animal Health to inquire about a product reimbursement and not to report the death of this animal. No more information is expected; this case is closed
Death
N - Unlikely Death is inconsistent with pharmaco-toxicological product profile and experience. 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, the reason for the initial call to Bayer was to inquire about product reimbursement and not to report the death of this animal. No signs of allergy/anaphylactic reaction reported. Even though some information (e.g. health status, time to onset and necropsy results) is not available, considering the known safety profile of the product and serious outcome of the case, a product involvement is deemed to be unlikely.