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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-0119

2. Registrant Information.

Registrant Reference Number: 2018BS050

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.

19-OCT-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

13-AUG-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).

1/2 tube of K9 advantix II XL was applied along the dorsal midline to Weimeriner dog, 11 years old, F/S, weighing 27.3 kgs on the 13th of each month since June 2018.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Weimeriener

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

27.3

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

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

11. List all symptoms

System

  • Skin
    • Symptom - Erythema
    • Symptom - Hair loss
  • Ear
    • Symptom - Other
    • Specify - hematoma
  • Nervous and Muscular Systems
    • Symptom - Head shaking

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 August 13th and Sept 13/18 dose the pet owner noticed the dogs ear would become red 12 hours after application. 12 hours after the October 13/18 dose the dogs ears were red. On October 15/18 the dog was experiencing hair loss at the application sites. On October 16/18 the dog was bathed with Chlorahexidine shampoo. The dog developed swelling at the tip of the ear which is possibly a hematoma. Dog will be examined


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

(name) was examined Oct 18/18. Owner reported erythemic ears 12 hours after application of K9 advantix II XL dog 1/2 tube on Oct 13/18. On Oct 15/18 owner noticed hair loss at the application site. (name) was bathed with Proseb shampoo on Oct 15/18. Since application (name) has been shaking head. On Oct 16/18, owner cleaned ears. On exam, Dr. (last name) did not find noticeable hair loss or alopecia at the application site. Looks like seasonal shedding. When ear was scoped, small amount of debris was found but nothing unusual on cytology at this time. Patient was dispensed Burrows Drop and will re-examine in 1 week, asked owner NOT to clean ears. Was also dispense Vanectyl-P for the Hematoma. Not convinced the K9 advantix II was the cause of the hematoma.