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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-5343

2. Registrant Information.

Registrant Reference Number: 2017RB072

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.

23-MAY-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

20-MAY-17

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: k9 advantix II 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).

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

shih tzu poodle crossbred dog

4. Number of animals affected

1

5. Sex

Male

Female

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

8.2

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Burns (superficial)
  • General
    • Symptom - Pain
  • Skin
    • Symptom - Inflammation of the skin
    • Symptom - Irritated skin

12. How long did the symptoms last?

Unknown / Inconnu

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

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

On May 18, 2017 the pet owner applied K9 Advantix II medium to their 4 year old, 8.2 kg, male neutered, Shih Tzu x Poodle crossbred dog. Two days later the dog was flapping its ears and was taken to a veterinary clinic for examination on May 21, 2017 and was found to have a superficial burn at application site, skin irritation, and pustules at the application site. The dog was bathed and treated with vitamin E topically, as well as other unknown treatments.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here