Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5807

2. Registrant Information.

Registrant Reference Number: 2018RB117

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.

29-JUN-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

27-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)

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

Product Name: K9advantixII 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 June 26, 2018 the pet owner applied K9 Advantix II medium to their 4.1 kg crossbred dog

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

Crossbred

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

4.1

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

• Skin
  • Symptom - Hair loss
  • Symptom - Discolouration
  • Symptom - Itchy skin
  • Symptom - Other
  • Specify - Clumping of hair

12. How long did the symptoms last?

Unknown / Inconnu

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

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

the following day the dog developed alopecia on right side of neck, had clumping of hair at the right side of neck, a greenish discoloration of the hair in that area, scratching at the right side of the neck. The dog was seen by a veterinarian who clipped and cleaned the area and recommended Viaderm.

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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

B - Possible Reported scratching is not expected to be localized on right side of the neck, but rather be linked to the application site. However, it may be a consequence of the uncomfortable feeling caused by the applied product. Alopecia and clumping of hair on the right side of the neck is not expected may be associated with reported scratching. Greenish discolouration of hair is not expected either and may have numerous other causes. Considering consistent time to onset, a product connection is deemed to be possible.