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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-2068

2. Registrant Information.

Registrant Reference Number: 2011TH007

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

Address: 77 Belfield Road

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-APR-11

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

03-APR-11

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. 27661      PMRA Submission No.       EPA Registration No.

Product Name: K9 advantix 20

  • Active Ingredient(s)
    • IMIDACLOPRID
    • PERMETHRIN

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).

Owner applied product the morning of April 2 to one application site

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

Shih Tzu - Poodle

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

5.2

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

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

11. List all symptoms

System

  • Skin
    • Symptom - Paresthesia
  • Nervous and Muscular Systems
    • Symptom - Restlessness
  • Skin
    • Symptom - Erythema
    • Symptom - Hyperesthesia
  • Nervous and Muscular Systems
    • Symptom - Muscle twitching
  • Skin
    • Symptom - Other
    • Specify - excoriation of lateral thorax

12. How long did the symptoms last?

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

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

Owner applied product on Saturday AM to two dogs. Owners were busy all day but noticed dog was restless Sat night and trying to get onto owner's bed. Owner noticed on Sunday AM that dog's skin was twitchy. Examined by vet April 4. Vet noted be was hyperesthetic and there was mild erythema of the skin along with some mild excoriation of the lateral thorax from the dog's attempts to scratch. Steroids and antihistamines prescribed. I spoke with O April 5. Owner had not yet applied vitamin E and felt dog was much better. Veterinarian prescribed steroids (0.2 ml dex sq and 2.5 mg pred to start April 5 and tapering over next 9 days). Also gave 0.25 ml antihistamine SQ. Owner was advised to apply vitamin E but had not as of follow up April 5.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

Classed as moderate as treatment given. Exposure shown as greater than 4 weeks as K9 advantix has at least 4 weeks activity.