New incident report
Incident Report Number: 2016-0699
Registrant Reference Number: 2015KP334
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: UNKNOWN
Unknown
PMRA Registration No. PMRA Submission No. EPA Registration No. Unknown
Product Name: advantage spot-on unknown
Liquid
Yes
Unknown
Site: Animal / Usage sur un animal domestique
Unknown
Other
Dog / Chien
Unknown
1
Unknown
Unknown
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>24 hrs <=3 days / >24 h <=3 jours
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unknown date post administration, in 2010, the dog died. It is unknown if the dog was euthanized or if a necropsy was performed. No further information is expected. This case is closed. 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 product use on her new cats and not to report the death of the patient. Follow up received: On an unknown date in 2010, a canine of unknown signalment and condition, with fleas, was administered 1 tube of Advantage (dog-unspecified) (Imidacloprid) topically by the owner.
Death
Death not expected after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergic/anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 20-fold over dosage tolerated by dogs without showing any side effect. No connection in time reported between treatment and death. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (5 years). Further, the owner did not believe in product involvement either as reason for the initial call was to discuss product use on another cats and not to report the death of this dog. Considering these aspects, in spite of the limited information (animal details, time to onset, absence of necropsy results and medical history), a product relation is unlikely.