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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7214

2. Registrant Information.

Registrant Reference Number: 130084917

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.

23-JUN-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

22-JUN-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. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot 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 June 22, 2013 the owner applied the product to the dog to prevent fleas.

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 Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8.0

7. Weight (provide a range if necessary )

13.0

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 / <=30 min

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Agitation
  • Respiratory System
    • Symptom - Panting
  • Skin
    • Symptom - Erythema

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

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

On June 22, 2013, right after the product had been applied, the owner noticed that the dog was symptomatic. Later that day the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that permethrin is a pyrethroid, and dogs generally tolerate permethrin well. The APSS veterinarian also stated that no life-threatening signs would be expected and that pyrethroids can cause a "pins and needles" sensation or hyperesthesia, resulting in reluctance to move, mild tremors, paw shaking, ear twitching, or facial fasciculations; some dogs could develop erythema and pruritus as well. The APSS assistant recommended that the owner bathe the dog with liquid dish washing detergent (LDWD), apply vitamin E and a cold compress to the dog's skin, take the dog to the veterinarian the next day if signs persisted, and call back with questions.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Signs are expected to be mild and self limiting.