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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-1654

2. Registrant Information.

Registrant Reference Number: 2014CK123

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

13-MAY-14

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

6. Date incident was first observed.

04-MAY-14

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. 27660      PMRA Submission No.       EPA Registration No.

Product Name: K9 Advantix 55

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2.5

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).

Max 14yr MN bichon (unknown weight) was treated with K9 Advantix 55 for the first time on May 4th, 2014. the product was applied in multiple spots down the back.

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

bichon frise

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

14

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

  • Skin
    • Symptom - Pruritus

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

Not recovered / Non 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

Later that evening, the owner reported that the dog became pruritic (all over the back). The owner bathed the dog 2 days later, due to continued pruritus. The owner then gave benadryl (unknown dose) at an unknown time following product applicaton. As of May 13th, 2014, the dog was improved but not completely recovered.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The owners other dog, an 8yr FS bichon frise had a similar reaction (2014CK124)