New incident report
Incident Report Number: 2017-0555
Registrant Reference Number: 2017KP063
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. 11556-155
Product Name: Seresto Collar - Large Dog
Other (specify)
collarYes
Other Units: collar
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 on other than the application site is not typically seen with topical product administration. Alternative causes (concomitant condition of pruritus and atopic allergies) are probable. Death is not expected following appropriate topical product application as inconsistent with product¿¿¿¿¿¿s pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. Owner does not believe in product connection as the caller contacted Bayer animal heath to inquire about another pet and not to report death of the dog. Time to onset of serious sign (in minimum over 6 month) is much too long. Even though some information missing (necropsy report, animal details), considering the known product profile sufficient information exists to conclude that the product did not cause the event and the product relation is deemed to be unlikely.