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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6974

2. Registrant Information.

Registrant Reference Number: 2013CK106

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.

11-DEC-13

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

27-OCT-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. 27584      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II (extra large dog)

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PYRIPROXYFEN

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).

11yr F (intact), 32.5kg GSD was treated for the first time with Advantage II extra large dog on October 26th and then again 1 month later (specific date unknown). Both treatments were applied in multiple spots along the back of the dog.

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

German Shepherd Dog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

32.5

kg

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 - Pruritus
    • Symptom - Erythema
    • Symptom - Lesion
    • Specify - superficial ulceration
    • Symptom - Red skin
    • Symptom - Dermatitis
  • Ear
    • Symptom - Other
    • Specify - otitis externa

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

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

24 hours after each application with Advantage II, the owner noted that the dog's skin appeared red and the dog was pruritic at the application sites. The dog also developed areas of superficial ulceration of the skin at the application sites. The dog presented to the veterinary clinic for its annual examination and vaccine on Dec 3rd. At that time, general physical examination showed evidence of flea allergic dermatitis, yeast dermatitis, scabs at the application site and otitis externa. The dog was treated for supect yeast dermatitis and otitis externa. The dog was switched to an alternative flea control but did not require specific medical treatment for a suspect reaction to advantage II. The dog was completely recovered at the time the report was made.


To be determined by Registrant

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

Minor

19. Provide supplemental information here