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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-4920

2. Registrant Information.

Registrant Reference Number: 2018EB109

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.

05-JUN-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-JUN-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 female spayed 3 year old 29 kg golden retriever. On June 1st, the pet owner applied 1 vial of K9 Advantix II extra-large dog topically on the patient. This patient was applied K9 Advantix II in May 2018 and multiple times in the summer season of 2017.

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

golden retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

29

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Renal System
    • Symptom - Urinary incontinence
  • Nervous and Muscular Systems
    • Symptom - Collapse
  • General
    • Symptom - Lethargy

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.

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

Approximately 30 minutes after the administration of the product, the dog lost her footing, collapsed and peed. The patient was not unconscious as she had her eyes open and was wagging her tail but wouldn't get up. The pet owner washed the dog with dish soap at the application site. The pet got up within an hour. The patient was quiet that evening but was back to herself on June 2nd. The outcome is recovered. The owner's other dog was dosed with a vial of K9 Advantix II extra-large dog from the same box without any reactions.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

O - Unclassifiable/unassessable Reported collapse and uncontrolled micturition are not expected after product application as inconsistent with pharmaco-toxicological profile of the product. Other causes should be considered. Even though more expected after oral uptake, permethrin has the potential to cause slight neurological disorders e.g. lost footing and unable to get up in particular susceptible animals. Being quiet is unspecific and may have numerous other causes in a dog. Though time to onset is short, considering overall aspects, a product involvement is unassessable.