New incident report
Incident Report Number: 2017-0527
Registrant Reference Number: 2017KP036
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. 11556-144
Product Name: k9 advantix II extra large dog
Liquid
Yes
Units: mL
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Great Dane
1
Female
Unknown
Unknown
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
Unknown / Inconnu
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
The dog was bathed on unknown dates in 2013, approximately every 3 days, with a medicated pet shampoo. On an unknown date in 2013, the pruritus resolved. On an unknown date in approximately May of 2013, the pruritus recurred. On an unknown date in approximately 2013, the dog was administered 1 tube of K9 Advantix II (unspecified) (imidicloprid-pyriproxifen-permethrin) topically by the owner. On an unknown date post product application, in approximately 2013, the pruritus resolved. No more information is expected. This case is closed. Follow up received on 02 Nov 2016: On approximately 01-Jan-2013, a neutered, female, Great Dane, of unknown age and weight, in good condition, with fleas, pruritus, and atopic allergies, bathed approximately every 3 days with a medicated pet shampoo in 2013, had 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar placed around the neck by the owner. On an unknown date in 2013, the concomitant pruritus resolved. On an unknown date post application, in approximately May 2013, the pruritus recurred; the collar was removed. On an unknown date post onset, in approximately 2013, the dog was administered 1 tube of K9 Advantix II Extra Large Dog (Imidacloprid-Pyriproxyfen-Permethrin) topically by the owner. On an unknown date post product application, in approximately 2013, the pruritus resolved. On an unspecified date, in approximately 2014, the dog died. It is unknown if a necropsy was performed. The caller contacted Bayer animal heath to inquire about another pet and not to report this event. No further information is expected. Case is closed.
Death
Pruritus was reported before application of product, therefore not related. Later reported death is not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. Very long time for reporting as the intent of the phone call to Bayer was to inquire about another pet and not to report this event. No signs of allergy/anaphylactic reaction reported. Even though time to onset unknown, occurrence of sign within window of allergic/naphylactic reaction (within 1 day) unlikely, as would have been reported in close proximity. Time to onset of serious sign (in minimum over 6 month) is much too long. Other etiologies more probable. Considering all aspects, product connection is deemed to be unlikely.