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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4420

2. Registrant Information.

Registrant Reference Number: 2018RB063

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.

25-MAY-18

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

24-MAY-18

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. 27582      PMRA Submission No.       EPA Registration No.

Product Name: advantageII Large Dog

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PYRIPROXYFEN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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 May 23, 2018 the pet owner applied Advantage II large to her 20.5 kg, female neutered, 14 month old Siberian Husky.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Siberian Husky

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.2

7. Weight (provide a range if necessary )

20.5

kg

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

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia

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

Unknown/Inconnu

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 following day the dog began vomiting, became lethargic, and anorexic. The pet owner suspects the dog ingested the product after application. The dog was taken to an emergency veterinarian. Repeated attempts to contact the pet owner have been unsuccessful, the outcome is unknown, and no further information is expected.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

B - Possible Vomiting is an unspecific sign and may have many potential other causes. Sign is not expected after topical product use and oral product uptake was not witnessed. However, a reaction to accidentally ingested product cannot be excluded in this case. Lethargy and anorexia likely associated with vomiting. Time to onset is consistent. A product relation is considered possible.