Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3330

2. Registrant Information.

Registrant Reference Number: 2011CP

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

Address: 77 Belfield Rd

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.

22-MAR-11

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

12-MAR-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)

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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).

one tube was applied to the back of the head

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

Animal's Owner

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 )

18

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

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

11. List all symptoms

System

• General
  • Symptom - Loss of balance

• Nervous and Muscular Systems
  • Symptom - Muscle weakness
  • Specify - weak in hind end

• Ear
  • Symptom - Other
  • Specify - discharge
  • Symptom - Other
  • Specify - mass deep in ear canal

• Renal System
  • Symptom - Other
  • Specify - mild renal insufficiency

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

Two days after application, owner noticed cat was losing balance and falling; On march 14, cat was examined: has discharge from left ear, seems to be a mass deep in ear canal; cat seems weak in hind end; Still has good appetite; cat has received advanatge numerous time over the past years and has never had a problem with it. Blood work shows mild renal insufficiency ; cat was treated with oral prednisone; cat was treated with advantage regularly for many years without any side effects

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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

cat seemed normal for 2 days before signs appeared; cat is geriatric and may have other underlying conditions; product is not absorbed systemically ; Reported signs are not typical with appropriate topical product administration. The product was used before without causing any signs. Described signs are consistent with an otitis.