New incident report
Incident Report Number: 2017-6926
Registrant Reference Number: USA-BAYERBAH-2017-US0057991 (Report 444108)
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: CALIFORNIA
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: Advantage Plus Spot-on pipette size unknown
Other (specify)
Spot-onYes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Unknown
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 approximately 01-Jan-2015, a canine of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II (dog-unspecified) (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. On an unspecified date in 2015 the dog had halitosis. On an unspecifed date in 2015 the dog passed away. It is unknown if a 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 inquire about Seresto use with another pet and not to report the death or the halitosis in this event.
Death
N - Unlikely Halitosis is an unspecific sign and may have many potential causes. Sign is not expected after topical product use and oral product uptake was not witnessed. 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, the reason for the initial phone call call was to inquire about Seresto use with another pet and not to report the death or the halitosis in this event. In case of suspected product involvement case would have been reported in close proximity and not after long time (2 years). Even though some information is not available (e.g. animal details, time to onset, health status, medical history and necropsy report), considering known product profile a product relation is unlikely.