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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-8171

2. Registrant Information.

Registrant Reference Number: 2017CP376

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.

27-NOV-17

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

11-NOV-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)

PMRA Registration No. 27583      PMRA Submission No.       EPA Registration No.

Product Name: Advantage II Medium Dog

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PYRIPROXYFEN

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 November 10 2017 , a 7 kg,4 year old male neutered canine shih tzu was applied one tube of advantageII medium dog, once topically by a veterinarian.

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

Other

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

7

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

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Loss of appetite
    • Specify - Decreased Appetite
  • Skin
    • Symptom - Itchy skin

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.

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

On November 10 2017 , a 7 kg,4 year old male neutered canine shih tzu was applied one tube of advantageII medium dog, once topically by a veterinarian. The day after application, dog had application site itching, decreased appetite and vomited once; reaction lasted 2 days


To be determined by Registrant

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

Minor

19. Provide supplemental information here

B - Possible Application site itching may be a dermal reaction at the application site in a particular sensitive animal. Vomiting is unspecific and may have many potential other causes. Sign is not expected after topical product use and oral product uptake was not witnessed. However, short time to onset and thus a reaction to accidentally ingested product cannot be excluded. Decreased appetite in this case may be associated with the vomiting. Time to onset is consistent. A product relation is considered possible.