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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4421

2. Registrant Information.

Registrant Reference Number: 2018RB064

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.

28-MAY-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

25-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. 29778      PMRA Submission No.       EPA Registration No.

Product Name: K9 advantix II Medium Dog

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

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).

On May 24, 2018 the pet owner applied K9 Advantix II medium to their 8.1 kg, male neutered, crossbred 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

Medical Professional

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 )

Unknown

7. Weight (provide a range if necessary )

8.1

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

  • General
    • Symptom - Discomfort
    • Specify - Uncomfortable
  • Skin
    • Symptom - Other
    • Specify - Application site weeping
    • Symptom - Irritated skin
  • Nervous and Muscular Systems
    • Symptom - Aggressive behaviour
    • Specify - Aggression

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

The following day the dog was uncomfortable and the pet owner washed the area with water. On May 26, 2018 the pet owner brought the dog to the veterinarian and there was oozing at the application site and the application site was irritated. The veterinarian clipped and cleaned the area under sedation as the dog was aggressive when the area was touched and the dog was treated with topical antibiotics.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

B - Possible Reported being uncomfortable is very unspecific sign. However, it may be a consequence of the uncomfortable feeling caused by the applied product. Application site irritation most likely reflects local dermal sensitivity to the product. Would not expect oozing at the application site directly related to product. However, dog may have scratched at application site which caused sign by self-trauma. Aggression is not expected after topical application of the product, however in this case it may be associated with reported application site irritation. Overall, considering consistent time to onset, a product connection is deemed to be possible.