New incident report
Incident Report Number: 2017-7504
Registrant Reference Number: USA-BAYERBAH-2017-US0070830 (Report 456543)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: GEORGIA
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
Pyrenean Mountain Dog
1
Unknown
Unknown
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
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 2014, a Great Pyrenees 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 approximately 2014, the dog died. No known 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 another Bayer product and not to report the death of this animal. No new 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. Other etiologies are more probable. Moreover, the reason for the initial call to Bayer Animal Health was to discuss another Bayer product and not to report the death of this animal. Though some information is not known (time to onset, age, state of health and necropsy details) considering known product safety profile and intent of the call, a product relation is considered unlikely.