Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-2069

2. Registrant Information.

Registrant Reference Number: 2011TH008

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.

22-MAR-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-NOV-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. 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).

Clinic records show client bought 6 pack of advantage 9 in Dec 2010. She may have been given a 10 and charged for a 9. Advantage 9 is the product as packaged for cats under 8 lbs.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Pomeranian

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

4

kg

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

Unknown / Inconnu

11. List all symptoms

System

• Skin
  • Symptom - Hair loss

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 called Bayer March 21 2011. Reports purchasing advantage in Nov 2010, applied advantage in Nov and Jan. Feels hair loss started in her pet at time of application in Nov, more in Jan and continues to now. Arranged exam at her veterinarian. On exam Mar 23 2010 Dr found very dull and sparse coat affecting all of body except legs and top of head. Scattered patches of alopecia behind neck, on ventral abdomen, caudal legs and caudal dorsum. Sparse coat on tail. No parasites seen. No excoriations. Round patch of hyperpigmented skin in dorsum. DDX parasites, fungus, allergies, homones, anagen/telogen defluxion. Dog is matted, could be result of combing or clipping out matts. Records in 09 report hair loss esp on dorsum, thought at that time to be from harness. Owner bought product (6 pack adv 9 )in Dec 2010. Owner may be mistaken in when she applied? And when hair loss first noted?

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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 given. Exposure is greater than 1 month as advantage has at least 4 weeks residual and was used twice. This case has been lost to follow up as client has not been returning calls.