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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4213

2. Registrant Information.

Registrant Reference Number: 2013TH130

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.

06-AUG-13

5. Location of incident.

Country: CANADA

Prov / State: NEW BRUNSWICK

6. Date incident was first observed.

30-JUL-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

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

Boston Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

15.8

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 - Red skin
  • General
    • Symptom - Swelling
  • Skin
    • Symptom - Hair loss
    • Symptom - Dermatitis
    • Specify - crusts
    • Symptom - Pain
    • Symptom - Inflammation of the skin
    • Symptom - Other
    • Specify - Thickened 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

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

Baxter is 7.5yr old m/n Boston terrier (15kg). His owner applied advantage 55 to back of the neck July 29th. Owners have applied Advantage in the past with no issues. The following day the skin at the application site appeared red and swollen. Several days later however, it had progressed to patchy alopecia, crusting and Baxter was very uncomfortable. The owner had been medicating at home with Viaderm ointment. On exan Aug 7 the area was clipped and cleaned. The skin underneath very inflamed and thickened as well. The skin was scrubbed with chlorhexidine scrub to remove crusts. Skin impressions show cocci bacteria and wbc's.Treated with Convenia 1.6mL SQ. Dexamethasone 0.25mg/kg IM once. Start prednisone 5mg PO SID for 10 days to reduce inflammation. Sent owner home with chlorhexidine scrub to clean. Plan for recheck in 10 days- sooner if no significant improvement.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here