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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-3824

2. Registrant Information.

Registrant Reference Number: 10-01-22767171

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.

26-MAY-10

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

Unknown

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.       PMRA Submission No.       EPA Registration No. 29909-2-2724

Product Name: Zodiac Fleatrol Flea and Tick Shampoo for Dogs and Cats

  • Active Ingredient(s)
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .5 %
    • PYRETHRINS
      • Guarantee/concentration .05 %

7. b) Type of formulation.

Liquid

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).

Product was inappropriately applied to underaged pet.

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

Dog / Chien

3. Breed

Mixed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

.11

7. Weight (provide a range if necessary )

20

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 - Pruritus
    • Symptom - Dermatitis
    • Specify - Dermal hot spots
    • Symptom - Erythema
  • General
    • Symptom - Biting
    • Specify - chewing on wood
  • Gastrointestinal System
    • Symptom - Diarrhea
    • Symptom - Vomiting
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Died

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

Product was applied to pet and 2 days later the dog became symptomatic. One week later, the dog was given another bath with the product . The owner called Petsmart and they directed her to apply Jergens lotion to the affected skin. One week following the second bath, Petsmart instructed her to give another bath with the shampoo. The dog was given a 4th bath. On May 5th, the pet died. The pet was never examined by a DVM during her illness and a necropsy was not performed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The product was not used according to label directions: Do not use on pets younger than 12 weeks of age. According to the specialist at Prosar Poison Control the described illness and death does not appear to be related to product exposure.