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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6829

2. Registrant Information.

Registrant Reference Number: 2013TH177

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.

04-DEC-13

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

26-SEP-13

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: advantage 55

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN

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

Product Name: flea shampoo

  • Active Ingredient(s)

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).

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

Daschund X

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

21

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • Skin
    • Symptom - Hair loss
    • Symptom - Itchy skin

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

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

Pet was treated with advantage 55 on Sept 20 2013 due to the presence of fleas. The pet was presented to the clinic for examination Oct 18 2013. The owner reported seeing application site hair loss beginning Sept 26 213. The dog was also bathed with flea shampoo Sept 27 2013. On exam Oct 18 2013 the DVM noted a 6 inch wide band of alopecia circling the dogs neck and including what is expected to be the application site. The area was also pruritic. This was the first dose dog has ever had of Advantage and no known other topical ever applied. The pet was treated with antibiotics and vanectyl P.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here