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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3164

2. Registrant Information.

Registrant Reference Number: 2013TH026

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.

08-MAY-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

05-APR-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. 27659      PMRA Submission No.       EPA Registration No.

Product Name: K9 advantix 100

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN

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?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Standard Poodle

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.75

7. Weight (provide a range if necessary )

24

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Abnormal gait
  • Eye
    • Symptom - Pupil dilation
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Loss of appetite
    • Symptom - Anorexia
  • Blood
    • Symptom - Thrombocytopenia
    • Specify - platelets were slightly low

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.

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 K9 advantix May 2. Owner presented pet to vet May 8 and advised pet fell asleep after application and then had dilated pupils and was wobbly for 12 hours beginning the day after K9 advantix application. Pet didnt eat Friday night or all day Saturday but was at kennel Saturday and Sunday. Owner reported pupils were dilated again for 12 hours beginning Sunday night. Dog vomited once May 6. The dog was also bathed May 6. The dog was normal on exam May 8. Bloodwork was drawn and amylase and monocytes were slightly elevated. Platelets were slightly low. US showed blood, WBC, bilirubin and protein but dog is not neutered. Only treatment given was canned food.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here