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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3412

2. Registrant Information.

Registrant Reference Number: 2011Th016

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 77 Belfield Road

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

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

Domestic Animal

4. Date registrant was first informed of the incident.

11-MAY-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

24-APR-11

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. 27661      PMRA Submission No.       EPA Registration No.

Product Name: K9 advantix 20

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN

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 x poodle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.75

7. Weight (provide a range if necessary )

5.09

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Paresthesia
    • Symptom - Erythema
    • Symptom - Hair loss
  • Gastrointestinal System
    • Symptom - Diarrhea
  • General
    • Symptom - Restlessness
  • Nervous and Muscular Systems
    • Symptom - Muscle twitching
  • Skin
    • Symptom - Skin sensitivity
    • Specify - skin was sensitive to touch

12. How long did the symptoms last?

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

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

Owner applied April 24 2011 to 4 spots on dog's back, within 5 hours the dog seemed uncomfortable. The pet was examined on April 25 2011, the skin on the pet's back was noted to be twitching, the dog was scratching. The skin was sensitive to touch, with erythema, alopecia and hyperpigmentation. The dog was restless and had mild diarrhea. The pet was treated with metacam on April 25 and then with benadryl and vitamin E at a recheck on April 27 2011.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Moderate as treatment given. Length on exposure is less than 1 month as a bath was given.