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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-2129

2. Registrant Information.

Registrant Reference Number: 2017BS007

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.

17-APR-17

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

12-MAR-17

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. 29780      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II large dog

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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 Mar 12/17 and April 13/17, 1 tube of K9 advantix II Med to a 13kg, 4 year old, MN, Pug in 4 spots along the dorsal mid-line by pet owner.

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

Animal's Owner

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 )

4

7. Weight (provide a range if necessary )

13

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

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • General
    • Symptom - Discomfort
  • Nervous and Muscular Systems
    • Symptom - Muscle twitching
    • Symptom - Shaking

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

Not recovered / Non rétabli

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

A few hours after application, owner noted that Moose seemed uncomfortable, his skin was twitching, and his muscles were shaking. She took him to an emergency clinic and he did not have a rash, DVM suspected back pain. The DVM dispensed Apoquel and methocarbamol at that time. The owner also have him a bath. When clinical signs did not resolve, owner took Moose to another DVM that dispensed tramadol and recommend a visit for acupuncture. Owner took Moose in for acupuncture, but a cold laser was recommended instead. She treated him with cold laser. His clinical signs improved. Caller reports that Moose was due to the next flea treatment on 4/13/17 and she called her DVM to ask about administration. Her DVM recommended administration again as the previous incident was not suspected to be an adverse reaction. Owner reports that 2 hours after the administration, Moose started having the same clinical signs. Owner was then told by a friend that it was likely paresthesia and to give diphenhydramine and apply Vitamin E. She has also given him a bath with Dawn dish soap.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here