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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-2713

2. Registrant Information.

Registrant Reference Number: 2012TH058

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.

22-MAY-12

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

19-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)

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Miniature Poodle

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4.5

7. Weight (provide a range if necessary )

14.3

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
    • Symptom - Red skin
  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Loss of coordination
    • Specify - dog seemed uncoordinated
  • Gastrointestinal System
    • Symptom - Drooling
  • Renal System
    • Symptom - Inappropriate urination

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.

No

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 the evening of May 18th. May 19 she noticed the pet was itchy at the application site and the site was a bit red. She rinsed the pet with water but did not apply vitamin E as was suggested by her vet. May 20th the owner feels the dog had a seizure. The owner was in the kitchen when the dog ran in from another room in the house. The dog seem uncoordinated and drooling and was stiff when the owner picked it up. After about a minute the owner placed the dog on the floor and it fell over. It then got up and went outside and urinated and defecated. The owner later found urine on the floor where she thinks the dog may have been laying before this episode.


To be determined by Registrant

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

Major

19. Provide supplemental information here