Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0212

2. Registrant Information.

Registrant Reference Number: 2017RB212

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.

14-NOV-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

15-OCT-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)

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PMRA Registration No. 29778      PMRA Submission No.       EPA Registration No.

Product Name: K9 advantix II medium dog

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

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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).

On October 15, 2017 the pet owner applied K9 Advantix II medium to their 7 year old, female spayed, crossbred/ pug dog. Within a few hours the dog became agitated and her skin was irritated.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

crossbred/ pug dog

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

Unknown

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

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

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Agitation

• Skin
  • Symptom - Irritated skin

• Nervous and Muscular Systems
  • Symptom - Lameness
  • Symptom - Difficulty walking

• Gastrointestinal System
  • Symptom - Vomiting

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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

Within a few hours the dog became agitated and her skin was irritated. The dog began to limp, had difficulty walking, and vomited. The pet owner called the veterinary clinic who advised to apply vitamin E and monitor. The dog recovered 48 hours later.

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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 Though would not expect generalised skin disorder after topical application, reported agitation and skin irritation may reflect paresthesia caused by permethrin. Vomiting is very unspecific sign and may have numerous other causes. Limping is not expected after product application as inconsistent with pharmaco-toxicological profile of the product. Other causes e.g. foreign body in paw or trauma should be considered. Walking difficulty is likely a consequence of reported limping. Considering overall aspects, a product connection is unassessable.