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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5924

2. Registrant Information.

Registrant Reference Number: 2018EB180

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.

18-JUL-18

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

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. 29778      PMRA Submission No.       EPA Registration No.

Product Name: K9advantixII medium dog

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN
    • PYRIPROXYFEN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

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).

The patient is a female 5.5 kg 9 year old maltese. In 2018, (exact application date unknown), the pet owner applied 1 vial of K9 Advantix II medium dog topically on the patient.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Maltese

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

5.5

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Skin
    • Symptom - Pruritus
  • Nervous and Muscular Systems
    • Symptom - Agitation

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

Fully Recovered / Complètement rétabli

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

Within 24 hours of application the patient became very itchy at application site and was agitated. The patient was bathed and recovered. The pet owner reapplied another vial of K9 Advantix II medium dog at another month in 2018. The same reaction occurred. The patient was bathed and recovered. The patient had received K9 Advantix II in 2017 without previous reactions.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

A - Probable Reported itchiness at application site and agitation may reflect paresthesia caused by permethrin. Moreover, same signs reported after subsequent product application as well. Considering consistent time to onset and application site involvement, a product connection is deemed to be probable.