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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-0469

2. Registrant Information.

Registrant Reference Number: 070057409

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.

07-JUN-07

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

07-JUN-07

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 June 6, 2007 at 7:00 pm CDT, the owner applied this product to her 1.5 year old, 16 pound, female, spayed, Pug. The product was applied dermally as a preventative measure.

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

Pug

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.5

7. Weight (provide a range if necessary )

16

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • General
    • Symptom - Lethargy
    • Symptom - Hiding
  • Nervous and Muscular Systems
    • Symptom - Shakiness
    • Symptom - Fasciculations

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?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Not recovered / Non 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 June 7, 2007 at 3:00 am, CDT, the owner noticed that the animal was hiding, experiencing fasciculations, and acting lethargic. On June 7, 2007 at 6:00 am, CDT, the owner bathed the pet with regular pet shampoo in attempts to rinse off the product. On June 7, 2007 at 12:00 pm, CDT, the owner took the dog to her regular veterinarian. At that time the regular veterinarian performed bloodwork and placed the dog on IV fluids. On June 7, 2007 at 2:01 pm, CDT, the owner called to report the exposure.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The Animal Product Safety Service (APSS) veterinarian discussed the safety profile of methoprene and permethrins in dogs. In general these agents are very well tolerated in dogs and significant signs are uncommon. The APSS veterinarian also discussed dermal reactions. The APSS veterinarian discussed that some dogs experience what we believe to be a dermal sensitivity, even when they have no overt signs of dermal irritation. The APSS veterinarian also explained that it is possible to see lethargy and behavior changes in those dogs. Signs usually resolve over the course of 48-72 hours. A follow- up on this case was not deemed necessary, therefore the outcome is unknown.