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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-1462

2. Registrant Information.

Registrant Reference Number: 33189

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.

14-MAY-20

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

07-MAY-20

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).

On 7-May-2020, a 9 month old, 29.6 kg, female spayed Golden Retriever in good condition with no concomitant medical conditions was administered one K 9 ADVANTIX II 6 X 4.0 ML EX LGE DOG, KP0DB9C KP0CVJV (-), by Animal owner. The product was used according to label (Yes).

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

Golden Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.75

7. Weight (provide a range if necessary )

29.6

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Diarrhea
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Lameness

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

On the same day as the application, the patient had diarrhea and vomited once. The patient also started limping from her hind right leg. The patient had another episode of vomiting on 09-May-2020. On 12-may-2020 the patient was seen for on-going diarrhea. The patient was treated with metronidazole and gastro intestinal food. This is a dog that has a history of chewing on wood and other things. On physical exam the veterinarian noticed that the patient was protecting her right hind leg, however she was not limping and the veterinarian was not able to locate a source of discomfort. The veterinarian does not think the vomiting diarrhea or limping was related to the application of K9 Advantix II. 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