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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2624

2. Registrant Information.

Registrant Reference Number: 2018EB026

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.

30-APR-18

5. Location of incident.

Country: CANADA

Prov / State: MANITOBA

6. Date incident was first observed.

29-APR-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: K9advantixII 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).

The patient is a golden retriever 9 months, female, 34 kg. The pet owner applied the K9 Advantix II extra-large dog April 29th 2017 at 5 pm.

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 )

34

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

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Abnormal behaviour
  • Renal System
    • Symptom - Lack of control of urination

12. How long did the symptoms last?

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

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

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

The patient vomited shortly after (food and bile) and urinated at the same time. The second time the patient vomited she seemed to be ataxic and stopped eating. The patient was brought to the emergency veterinary hospital. At the assessment at the emergency hospital, the patient was bright and alert and no ataxia was noted. The patient had not vomited since 7 pm. The patient was treated with Cerenia and Benadryl. The outcome is recovered. The patient had been drinking out of the lake and possibly out of the ditch that day.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

B - Possible Reported vomiting more expected after oral uptake than after dermal application of the product. However, an oral uptake cannot be excluded. Appetite loss likely consequence of vomiting. Urination may be behavioural response to product sensation than true renal disorder. Even though more expected after oral uptake, Permethrin has the potential to cause slight neurological disorders (e.g. ataxia) in particular susceptible animals. Considering consistent time to onset, a product connection is deemed to be possible.