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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7224

2. Registrant Information.

Registrant Reference Number: 130093801

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.

09-JUL-13

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

25-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. 28382      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Dual Action Flea And Tick Spray For Cats And Kittens

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

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).

Beginning on June 16, 2013 and continuing every 2 to 3 days until June 30, 2013 the owner sprayed the cat with the product to treat for fleas. Starting on July 1, 2013 and continuing every 2 to 3 days, the owner then applied another brand of flea and tick spray to the cat after running out of the Zodiac product.

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Himalayan

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

12.0

7. Weight (provide a range if necessary )

4.6

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Skin
    • Symptom - Pruritus
    • Symptom - Lesion
    • Specify - Abscess
    • Symptom - Hair loss

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 25, 2013 the owner observed that the cat was lethargic, pruritic, had an abscess that was thought to be unrelated to product use, and had alopecia. On July 9, 2013 the owner's emergency veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that local dermal irritation and itching could be seen and that the risk with the second flea and tick spray was for lethargy, depression, and weakness. The APSS veterinarian recommended that the emergency veterinarian bathe the cat, provide fluid therapy, provide symptomatic and supportive care, and give the cat Diphenhydramine.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

The APSS veterinarian stated that flea infestation was considered to have a medium likelihood of causing the clinical situation. Extra Label Use animal was sprayed more than labelled once per week.