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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3000

2. Registrant Information.

Registrant Reference Number: 2013TH047

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-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

06-MAY-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

Schnauzer

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

11.2

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

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Loss of appetite
    • Specify - not eating well
  • Skin
    • Symptom - Dermatitis
    • Specify - crusty lesions on both ears and left ventral abdoment
  • Nervous and Muscular Systems
    • Symptom - Agitation
  • Gastrointestinal System
    • Symptom - Other
    • Specify - elevated lipase
  • General
    • Symptom - Biting
    • Specify - chewing at legs

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

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 5 2013. Owner noted dog was lethargic May 6. Owner gave pet a bath May 7. Pet was examined May 9. The pet was agitated and chewing at legs and rubbing application sites against furniture. There were crusty lesions on both ears and the left ventral abdomen, likely from self trauma. Cephalexin was prescribed. May 10 the pet was still lethargic and not eating well. May 12 the dog developed diarrhea and vomiting. The pet was examined May 13 and new lesions similar to those seen May 9 had developed on the abdomen. Cephalexin was stopped and clavasept was prescribed. Bloodwork revealed elevated lipase and CPL. The pet was placed on IV fluids and given torbugesic. The dog was discharged the next day and doing well per owner May 15. The skin lesions were healed by May 23 2013 and the pet deemed to be fully recovered.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here