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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4513

2. Registrant Information.

Registrant Reference Number: 2013TH135

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.

28-JUL-13

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

28-JUL-13

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)

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

Product Name: K9 advantix 20

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN

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

mixed breed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

11

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Eye
    • Symptom - Red eye
    • Symptom - Swollen eye

12. How long did the symptoms last?

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

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

On 27-Jul-2013, a 4 year old, 22.00 pound, spayed, female, Unknown Breed canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix 20 (Imidacloprid - Permethrin) once topically by the owner. On 27-Jul-2013, this dog was also administered an unknown amount of ivermecitn once orally by the owner . On 28Jul2013 the dog had periorbital edema and eye redness. On 29Jul2013 the dog was examined by the veterinarian and treated with diphenhydramine. On 30Jul2013 the dog was recovered.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here