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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-5413

2. Registrant Information.

Registrant Reference Number: 09-01-19957175

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.

15-SEP-09

5. Location of incident.

Country: UNITED STATES

Prov / State: MINNESOTA

6. Date incident was first observed.

14-SEP-09

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. 68688-41-2596

Product Name: Hartz Ear Mite Treatment for 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 the under aged pet on September 14th.

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

Domestic Short Hair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.12

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Lethargy
    • Symptom - Hypothermia
  • Blood
    • Symptom - Anemia
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

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

Staff veterinarian recommended that the kitten's ears be flushed to remove any remaining product, wrap the cat in warm blankets to try to assist in maintaining body temperature. The kitten was also anemic. The kitten was given an IV dex injection and the owner elected to take the kitten home for the night. The kitten passed away the same night.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Product was not used according to label directions: do not use on kittens less than 12 weeks of age. According to the Posar specialist, these types of symptoms would not be expected.