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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4440

2. Registrant Information.

Registrant Reference Number: 2018BS011

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.

17-MAY-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-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).

K9 advantix II XL was applied to x a M/N, 30.5kg Alaskan Malamute X on May 1st 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

Crossbred (Dog)

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

30.5

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

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

11. List all symptoms

System

  • Skin
    • Symptom - Itchy skin
    • Symptom - Hyperesthesia
    • Specify - Twitching
  • General
    • Symptom - Pacing
  • Skin
    • Symptom - Dermatitis
    • Specify - Application site hot spot

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

Within 2-4 hours of application x became itchy, twitching skin and was pacing. By May 4th he developed a hot spot (moist dermatitis) at the application site. x was seen by at the Alta Vista AH on the evening of May 4th. He was sedated to clip and clean the wound area. He was given a course of treatment which included Cephalexin 250 mg, Gabapentin 300mg, Cortavance Spray and Isoderm Gel. Owner mentioned that when she applied K9 advantix II XL to x last year he developed a hot spot after each application during the tick season months. She does not recall the application dates.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

B - Possible Though would not expect generalised skin disorders after topical application, reported itching, twitching and pacing may reflect paresthesia caused by permethrin. Whereas skin reaction at application site, e.g. pruritus or erythema may occur in sensitive animals, would not expect hot spot development directly related to product. However, likely linked to scratching at application site which caused sign by self-trauma, which secondarily became infected with bacteria. Considering consistent time to onset, a product connection is deemed to be possible.