Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-1831

2. Registrant Information.

Registrant Reference Number: 2014CK130

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.

21-MAY-14

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

14-MAY-14

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. 27660      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix 55

• Active Ingredient(s)
  • IMIDACLOPRID
  • PERMETHRIN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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).

A 15yr 33lb FS wheaten terrier was treated with K9 Advantix 55 on May 14th 2014. The product was applied in 3 locations down the dog's back.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

wheaten terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

15

7. Weight (provide a range if necessary )

33

lbs

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 - Pruritus

• Nervous and Muscular Systems
  • Symptom - Bizarre behaviour

• Skin
  • Symptom - Hair loss
  • Symptom - Erythema

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Not recovered / Non 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

The owner reported that the dog began pacing immediately following product application (bizarre behaviour). The next day the dog was examined by a veterinarian for another unknown issue - no abnormalities were reported at that time. The dog was pruritic at the application sites on may 17th . An area 2 inches in diameter on the dogs mid-back at one of the application sites became red with some hair loss. the owner appied polysporin to the area on May 17th and bathed the dog on may 19th with dish soap. The dog is still pruritic at the middle application site at the time of the report

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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

The pet owner applied k9 advantix 20 to a smaller dog at the same time. No adverse reaction was noted.