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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-5754

2. Registrant Information.

Registrant Reference Number: 080082142

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.

26-JUL-08

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

24-JUL-08

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. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea And Tick Control For Dogs Over 14 kg

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2

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 July 22, 2008, the owner applied the product to her dog 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

Great Dane

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

150

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Skin
    • Symptom - Erythema
    • Symptom - Lesion
    • Specify - Pustules

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?

Unknown

14. b) How long was the animal hospitalized?

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

The owner took the animal to the local veterinarian where the attending veterinarian prescribed metronidazole, advised the owner to bathe the animal, and recommended the owner apply Surolan to the effected area twice a day. The APSS veterinarian stated that use of the product, per label, is not expected to lead to signs. The APSS veterinarian recommended the owner bathe the animal again in liquid dish washing detergent, apply vitamin E to the area, monitor the animal for continued or worsening dermatological signs and take the animal to the local veterinary clinic for further treatment if needed. The owner stated that on July 26, 2008, she took her animal back to the local veterinary clinic where the attending veterinarian prescribed Cephalexin, advised the owner to discontinue the metronidazole, provided wound care with an antibacterial shampoo, and expressed the animal's anal glands. The owner stated that on July 28, 2008, after three doses of the Cephalexin, there was no evidence of pustules on the animal's skin. The animal is still suffering from erythema; however, the sign has not increased in severity.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here