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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6511

2. Registrant Information.

Registrant Reference Number: 1-34838497

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.

05-SEP-13

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

31-AUG-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. 2724-504-2596

Product Name: Hartz UltraGuard Pro Flea and Tick Drops for Cats 5lbs 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 August 31, 2013 caller applied product to cat.

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

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Salivating excessively
    • Symptom - Vomiting
  • General
    • Symptom - Death
    • Symptom - Hiding
  • Nervous and Muscular Systems
    • Symptom - Skittish
    • Specify - skittish

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

On August 31, 2013 caller applied product to her husbands cat and it became symptomatic. Owner reports that the animal is typically skittish but then hid consistently. On morning of September 5, 2013 cat was found dead. The owner wishes a necropsy to be performed but cannot find a vet clinic for body transport.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Staff veterinarian determined to be doubtfully related to product use.