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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4779

2. Registrant Information.

Registrant Reference Number: 2016RB031

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.

16-AUG-16

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

15-AUG-16

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. 29777      PMRA Submission No.       EPA Registration No.

Product Name: k9 advantix II small 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).

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

chihuahua

4. Number of animals affected

1

5. Sex

Male

Female

6. Age (provide a range if necessary )

2

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Skin
    • Symptom - Pruritus
    • Symptom - Erythema
    • Symptom - Other
    • Specify - pyoderma

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

"Cooper" (name) a 2 year old male/neutered chihuahua mix. Owner gave him a bath yesterday (August 14, 2016) at 5pm then applied Advantix at 8pm. Owner woke at 5am with the dog intensely pruritic and scratching his neck/back quite aggressively. Owner gave him a 2mg/kg dose of Benadryl at 6am, which seemed to help the pruritus and diffuse erythema along the back. Patient presented this afternoon at 2pm with a focal area (1x2cm) of moist, deep pyoderma at the back of the neck, corresponding to where the Advantix was applied. We clipped and cleaned the wound and applied Theraderm cream. Owner was advised to apply Theraderm BID until healed and to continue 2mg/kg Diphenhydramine Q8-12 hours for the next 48 hours.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here