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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4445

2. Registrant Information.

Registrant Reference Number: 2018BS016

Registrant Name (Full Legal Name no abbreviations): Bayer inc

Address: 2920 Matheson Blvd

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

25-MAY-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

11-MAY-18

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. 29779      PMRA Submission No.       EPA Registration No.

Product Name: K9 advantix II Extra Large Dog

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN
    • 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).

1 tube K9 advantix II XL purchased in 2017 was applied to x a 4 year old, M/I, 40 kg Golden Retriever on ~May 11th/18 along the dorsal midline.

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

Golden Retriever

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

40

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Skin
    • Symptom - Itchy skin
  • General
    • Symptom - Hyperactivity
  • Skin
    • Symptom - Other
    • Specify - Application site moist eczema
    • Symptom - Lesion
    • Symptom - Dermatitis

12. How long did the symptoms last?

Unknown / Inconnu

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

. Immediately after dose the owner noticed x was itchy and restless. On May 14/18 they noticed 1 patch of moist dermatitis at the base of his neck. The owner shaved the area and applied Topagen spray to the wound from a hot spot treated in June 2017. The wound became worse and on May 19th the dog was taken to another veterinary hospital. The back was shaved and other areas of moist dermatitis were uncovered along the dorsal midline. The dog was prescribed Metacam 1.5mg/mL, Topagen Spray and Clavaseptin 500mg 1 tab BID for 10 days


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

O - Unclassifiable/unassessable Though would not expect generalized skin disorders after topical application, reported itching and restlessness may reflect paresthesia caused by permethrin. Would not expect moist dermatitis at the base of neck directly related to product, however, may be dog scratched at site and caused sign by self-trauma. Further worsening of the wound is not expected either after topical product application and may have numerous other causes. Moreover, wound was pre-exiting. Though time to onset is long (3 days and more) for later reported worsening of wound, considering consistent time to onset for other reported signs and application site involvement, a product connection is unassessable.