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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2761

2. Registrant Information.

Registrant Reference Number: 2020RB007

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.

22-JUL-20

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

Unknown

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. 29777      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II small 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 15-Jul-2020 a 3.1 kg, male meutered, 2 year old maltipoo canine was applied one K9 Advantix II SMALL DOG by animal owner. The product was used according to label(Yes) Please note on 1-Jul-2020 the pet owner applied one Advantage Multi 10 The dog received this medication in the past without issue.

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

Maltipoo

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

3.1

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Skin
    • Symptom - Discolouration
    • Symptom - Other
    • Specify - Hair length change

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

No

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 1 Jun 2020 a 3.1 kg, male meutered, 2 year old maltipoo canine was applied advantage multi 10 by animal owner. The dog received this medication in the past without issue. The product was used according to label. On 15 Jun 2020 the pet owner applied K9 Advantix II small dog. In the middle of June 2020 the pet owner noted the hair at the application site changed in color and the fur was shorter. On 1 Jul 2020 the pet owner applied another dose of advantage multi 10. On 14 Jul 2020 the pet owner reported to the veterinary clinic 2 sites of fur discoloration at the application site and hair length change (shorter). On 15 Jul 2020 the pet owner applied another dose of K9 Advantix II small dog. On 22 Jul 2020 the dog was examined by a veterinarian who confirmed the hair discoloration at the application site and hair length change at the application site. The outcome is unknown.


To be determined by Registrant

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

Minor

19. Provide supplemental information here