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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-0553

2. Registrant Information.

Registrant Reference Number: 070102615

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

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1G 5L3

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

Domestic Animal

4. Date registrant was first informed of the incident.

27-SEP-07

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

26-AUG-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. 26413      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Double Action Flea And Tick Shampoo

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

PMRA Registration No. 26496      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On Flea Control For Cats And Kittens

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 August 25, 2007, the cat was bathed and treated with both products. On September 8, 2007, the cat was bathed with the shampoo product again as well as a competitive flea and tick mousse.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Erythema
    • Symptom - Itchy skin
    • Symptom - Dermatitis
  • Renal System
    • Symptom - Inappropriate urination
    • Specify - inappropriate urination
  • General
    • Symptom - Hesitancy to move

12. How long did the symptoms last?

Unknown / Inconnu

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

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 APSS staff member stated that there is a risk for dermal hypersensitivity, especially with all the other flea control products being used as well. The APSS staff member recommended that the owner give the cat a bath with liquid dish washing detergent , take the cat to the veterinarian, and have the veterinarian call back for information. The staff member also recommended that the owner give the cat diphenhydramine for pruritus, but it was unlikely to control signs. It was also recommended that the owner call a pest control operator, for an environmental treatment of fleas, and to discontinue use of all the over the counter products until the cat has been examined by a veterinarian.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

One week after the initial application, the shampoo was reapplied. The owner then used a flea mousse on the cat. Inappropriate use of product. Label states; "if sensitivity signs continue; consult a veterinarian immediately."