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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3417

2. Registrant Information.

Registrant Reference Number: 2011TH021

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.

26-MAY-11

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

6. Date incident was first observed.

24-MAY-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

Pomeranian X

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

9.8

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Paresthesia
    • Symptom - Erythema
  • General
    • Symptom - Discomfort
  • Nervous and Muscular Systems
    • Symptom - Agitation
  • General
    • Symptom - Vocalizing

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

Owner applied K9 advantix to 2 dogs May 23 2011, by May 24, one dog was very itchy. This dog had used Defend last year with no concerns. On exam on May 25 2011 the veterinarian noted a 6 cm by 8 cm area of erythema. The dog was very agitated and would scream when the area was touched. The dog was trying to scratch the area. Vitamin E was applied and diazepam was prescribed along with metacam. The area was washed 3 times by the owner and once by the veterinarian. May 27 2011 the owners noted he was still itchy but not scratching as much and seemed calmer. He had scratched an area raw overnight and the owner returned to the clinic May 27 for another exam.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here