Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-6037

2. Registrant Information.

Registrant Reference Number: 2010TH025

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.

29-JUL-10

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

16-JUL-10

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)

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PMRA Registration No. 27658      PMRA Submission No.       EPA Registration No.

Product Name: K9 advantix 10

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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

One Maltese (Ally), One Chihuahua X

4. Number of animals affected

2

5. Sex

Male

Female

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Skin
  • Symptom - Itchy skin
  • Symptom - Red skin
  • Symptom - Hair loss

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

Owner applied K9 advantix to MN Chihuahua X, 5.5 years old, 3.9 kg with existing allergic skin disease and to an 11 yr old FS Maltese, 5.6 kg with an existing heart condition. This pet is also on spironolactone and enalapril. The product was applied the evening of July 15. On July 15 it was noted that the dogs were itchy and there was some redness and hairloss at the application site. The dogs were examined by the veterinarian and given diphenhydramine injections and vitamin E capsules to apply to the skin where the K9 advantix had been applied. By July 20 both dogs had returned to normal.

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To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Classed as moderate as treatment was given. Exposure is listed as greater than 1 month as K9 advantix has at least 4 weeks residual activity.