Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-4677

2. Registrant Information.

Registrant Reference Number: 2009TH052

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

Address: 77 Belfied 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.

02-OCT-09

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

08-JUL-09

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. 25128      PMRA Submission No.       EPA Registration No.

Product Name: advantage 9

• Active Ingredient(s)
  • IMIDACLOPRID

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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).

Owner purchased a single tube from clinic. Pet was not a patient at that clinic and had not been seen elsewhere. It is unknown if the package insert or application instructions were provided to the owner.

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

Cat / Chat

3. Breed

Domestic

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

3

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

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

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

On examination, the veterinarian noted a 2 cm area on the back of the neck with dry itchy skin with some hair loss. It appeared that the cat had also created some scratches on the skin through self-trauma. Surolan was prescribed to be applied to the affected area twice daily for 7 days.

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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

Reaction classed as moderate as medical treatment was given. Time of exposure is listed as 1 month as the product has at least 4 weeks activity and was not washed off the cat.