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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4418

2. Registrant Information.

Registrant Reference Number: 2018RB061

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: ALBERTA

6. Date incident was first observed.

23-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 23, 2018 the pet owner applied K9 Advantix II medium to their 9.8 kg, male neutered, 9 year old Shih Tzu.

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

Shih tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

9.8

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Discomfort
  • Nervous and Muscular Systems
    • Symptom - Anxiety
  • Skin
    • Symptom - Itchy skin
  • Respiratory System
    • Symptom - Panting
  • General
    • Symptom - Vocalizing

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

That evening the dog was uncomfortable, anxious, itchy, panting, and barking. The dog was examined by the veterinarian May 24 and made the recommendation that the dog be bathed. As the veterinarian recommended treatment the case is considered moderate. The outcome is unknown.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

B - Possible Itching is not expected to be generalized but rather be linked to the application site. Reported behavioural disorders are very unspecific. However, signs along with itching may be a consequence of the uncomfortable feeling caused by the applied product. Panting is not expected and may rather be a behavioural reaction to product sensation than a sign of respiratory illness. Considering consistent time to onset, a product involvement is deemed to be possible.