Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-2074

2. Registrant Information.

Registrant Reference Number: 2011TH013

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.

27-APR-11

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

22-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)

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PMRA Registration No. 27661      PMRA Submission No.       EPA Registration No.

Product Name: K9 advantix 100

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN

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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

Lhaso Apso

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

14

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Loss of appetite

• Nervous and Muscular Systems
  • Symptom - Head shaking
  • Specify - shaking head

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 product about April 16. Intereptor Green was given April 14, owner noted dog reacted poorly to revolution last year. The following Friday (April 22)she took her dog to the vet for examination as they felt the dog had been shaking his head. The veterinarian found signs of mild inflammation in the dogs ears and prescribed an ear medication. A heart murmur was noted for which the owner declined treatment despite noting exercise intolerance. April 25 the owner had the dog re-examined by a different clinic and pre-exsiting iris synecis was noted with absent PLR, lymph nodes may be slightly enlarged but may be normal for this dog. no other abnormal finding other than heart murmer, owner reported dog was lethargic and not eating well. CBC showed mild decrease in WBC. (5.2 x103/mm3 - Normal 6 - 17) MCHC, monocytes and granulocyes als0 slightly low. Owner called Bayer April 27 but did not report itchiness until after discussion of paraesthesia. Repeat blood work April 29 shows all values normal except moncytes remain low and MCHC low but was run on in clinic machine, dr not concerned with these values. Lymph nodes unchanged, may be normal for this dog.

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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 only as moderate as dog was treated. Exposure unknown as it is unclear whether or not a bath was given at sometime.