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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0527

2. Registrant Information.

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

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

27-JAN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

Unknown

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-144

Product Name: k9 advantix II extra large dog

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %
    • PYRIPROXYFEN
      • Guarantee/concentration .46 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

4

Units: mL

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On approximately 01-Jan-2013, a neutered, female, Great Dane, of unknown age and weight, in good condition, with fleas, pruritus, and atopic allergies, had 1 Seresto Large Dog(Flumethrin-Imidacloprid) collar placed around the neck by the owner.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Dog / Chien

3. Breed

Great Dane

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Pruritus

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(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.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

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.