New incident report
Incident Report Number: 2017-6937
Registrant Reference Number: USA-BAYERBAH-2017-US0059970 (Report 445858)
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: UNKNOWN
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
English Springer Spaniel
1
Male
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 2016, a male, Spaniel - Springer (Unspecified) dog, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Large Dog (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. On an unspecified date in approximately 2016, post application, 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 phone call was to inquire about product expiration date and not to report the death in this event. No further information is expected.; the case is closed Note: Previous exposure was well tolerated by animal.
Death
N - Unlikely Death is not expected after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergy/anaphylactic reaction reported. 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. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after. Moreover, the reason the initial phone call was to inquire about product expiration date and not to report the death of the dog. Previous exposure was well tolerated by animal. Even though, some information( time to onset, no necropsy report) available, considering safety profile of the product, a product relation is unlikely.