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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-2863

2. Registrant Information.

Registrant Reference Number: 130029513

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.

08-MAR-13

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

08-JAN-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.       PMRA Submission No.       EPA Registration No. 2724-504

Product Name: Zodiac Spot On Plus Flea And Tick Control For Cats 5 Pounds And Over

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 40 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.8

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 January 5, 2013 the owner applied the product to the cat as a preventative.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11.0

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Abnormal behaviour
    • Specify - Behavior Change
  • Nervous and Muscular Systems
    • Symptom - Stiffness
  • General
    • Symptom - Pain
  • Eye
    • Symptom - Pupil dilation
  • Gastrointestinal System
    • Symptom - Other
    • Specify - Tongue Protrusion
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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

On January 8, 2013 the owner noticed that the cat had isolated incidents of symptoms. The owner took the cat to an emergency veterinarian that day after the signs developed, and the cat had fully recovered by the next day. Then, on January 10, 2013, the owner noticed that the cat had isolated incidents of the exact same symptoms as before. The owner took the cat to his regular veterinarian that day, where a diagnostic evaluation was performed and the cat was sent home. On February 5, 2013 the cat experienced all of the same signs as had previously been noted and died immediately after they began. On March 8, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the cat's signs were suggestive of blood clots and that although the etofenprox agent may cause some hair loss, redness, hiding behavior, and foaming due to the taste or scent of the product, the cat's signs would not be expected. A necropsy was not available due to the amount of time that had passed since the cat died.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to the clinical situation and that cardiomyopathy was considered to have a higher likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected.