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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7664

2. Registrant Information.

Registrant Reference Number: 2016MA073

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.

06-JUN-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

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. 29780      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II large dog

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN
    • 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 19th a dose of k9 advantix II L was given topically in several spots by an owner to a 12yr 12.3kg neutered male cocker poodle cross.

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

Cocker poodle cross

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

12.3

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Skin
    • Symptom - Pruritus
    • Symptom - Red skin
    • Symptom - Dermatitis

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

Yes

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

Over an unknown period of time the skin became hot and red, pruritic, warm to touch all over, even sites where they didn't apply the product, mostly the neck and hips. The dog was brought in for an exam on May 19th. Vet recommended washing, vitamin E, cold packs. By May 24th the dog was back to normal.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here