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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0015

2. Registrant Information.

Registrant Reference Number: 090125923

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G5L3

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

Domestic Animal

4. Date registrant was first informed of the incident.

11-NOV-09

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

10-NOV-09

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. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control for Dogs under 14 kg

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • 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).

On November 10, 2009 the owner applied the product to the dog.

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

Maltese Dog Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

4

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Skin
    • Symptom - Itchy skin
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking
    • Specify - Dragging Rear Legs
  • General
    • Symptom - Biting
    • Specify - Chewing Feet
  • Nervous and Muscular Systems
    • Symptom - Fasciculations
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
  • Skin
    • Symptom - Erythema

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.

No

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

On November 11, 2009 the APSS technician stated some animals are more sensitive to the ingredients in the product and can experience a dermal reaction. The APSS technician relayed the APSS veterinarian's recommendations to bathe the dog with liquid dish washing detergent (LDWD), apply vitamin E and a cold compress to the application area, monitor for dermatological signs including continued redness or irritation, discuss other flea preventatives with the veterinarian, and call back with questions.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

On November 18, 2009 an APSS technician contacted the owner to follow up the case. The owner stated she had bathed the dog with LDWD, applied vitamin E and a cold compress to the application area, and monitored the dog at home for continued dermatological signs. The owner reported the dog's signs ended on November 16, 2009, and the dog had made a full recovery.