Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2012-2714

2. Registrant Information.

Registrant Reference Number: 2012TH059

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.

24-MAY-12

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

20-MAY-12

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. 27659      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.

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

Rottweiler

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

84

lbs

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

• Gastrointestinal System
  • Symptom - Diarrhea
  • Symptom - Vomiting

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 May 19 2012 and noticed the dog became itchy at the application sites. The dog was examined and prescribed prednisone May 22 2012. The dog returned to normal by May 24 2012.

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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

Status update: Update June 29 2012 - fax from clinic that dog re-examined as had intermittent vomiting and diarrhea since advantix application. Called clinic as this was not reported in initial comments. Diarrhea and vomiting didn't start for until about 10 days after application and about 5 days after prednisone started. Was treated with cerenia.