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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6865

2. Registrant Information.

Registrant Reference Number: 2018EB237

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.

09-OCT-18

5. Location of incident.

Country: CANADA

Prov / State: NEW BRUNSWICK

6. Date incident was first observed.

03-OCT-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: K9advantixII 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).

The patient is a sheltie 3 year, MN, 18.15kg.The patient is in good health, this is an epileptic patient that is treated with phenobarbital and potassium bromide and his seizures are generally well controlled.On October 3rd. The pet owner applied 1 vial of K9 Advantix II medium dog. This was not the patient's first dose, there is no previous history of reaction.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Sheltie

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

18.15

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Stiffness
    • Symptom - Shaking

12. How long did the symptoms last?

>30 min <=2 hrs / >30 min <=2 h

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

Fully Recovered / Complètement 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

7 hours after application, the patient had a seizure. The patient was still standing but he was very stiff and his head was extended and shaking (this is typical for the type of seizure this patient usually has). The seizure lasted approximately 45 minutes. The patient was not seen in a vet clinic or treated that day, other than his normal seizure medication. As of October 10th, there have been no other seizures since October 3rd. The outcome is recovered.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

O - Unclassifiable/unassessable It is known that, at recommended dosage, none of active ingredients in the product have the potential to provoke seizures in dogs neither alone nor in combination. Only mild neurological signs, e.g. tremors or ataxia, may occur even after oral uptake. As dog showed epilepsy prior to product use, seizures are likely related to this underlying condition. In such patients, anything may trigger an attack. Stiffness and head shaking likely only consequence of reported seizures. Previous exposure was well tolerated. Though short time to onset, considering medical history, a product relation remains unassessable.