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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6857

2. Registrant Information.

Registrant Reference Number: 2018BS048

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-OCT-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-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).

Owner applied contents of one tube of K9 advantix II XL to an 8 year old German Shepherd, F/S weighing 29.1 kgs along the spine and over the hips on there dog on April 1/2018 and May 1/2018.

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

German Shepherd Dog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

29.1

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

  • Nervous and Muscular Systems
    • Symptom - Shaking
  • Skin
    • Symptom - Hyperesthesia
    • Symptom - Lesion

12. How long did the symptoms last?

Unknown / Inconnu

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

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

Owner noted that within a couple of hours of application dog started shaking and had skin twitching. Two to three days later scabs appeared on her skin in the areas it was applied. Mrs. did not notice dog scratching at any point. Dog was new to them so no previous history.


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 Even though more expected after oral uptake, Permethrin has the potential to cause slight neurological disorders (e.g. twitching ) in particular susceptible animal. Though sign very unspecific and not expected, shaking may be a consequence of the uncomfortable feeling caused by the applied product. Moreover, in this case may be associated with the reported twitching. Further reported scabs are not expected after product application. The observed skin reactions may be associated with the dog's scratching at affected sites. Pruritus was not reported though. Other causes should be considered. Though time to onset is consistent for initial signs, considering long time to onset for further reported sign (2 days and more), a product connection is considered unassessable.