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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1014

2. Registrant Information.

Registrant Reference Number: 1-30054031

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.

09-MAY-12

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

25-APR-12

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: UltraGuard Plus Drops for Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Unknown
    • ETOFENPROX
      • Unknown

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).

Owner inappropriately applied to under aged animal.

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

Cat

4. Number of animals affected

2

5. Sex

Unknown

6. Age (provide a range if necessary )

0.08

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • 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?

Other / Autre

specify contact with nursing mother who had been treated with product

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

Veterinarian called to report the death of two 4 week old kittens after product was inappropriately applied to their nursing mother.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Label directions were not followed. Label states: Do not use on kittens less than 12 weeks old. Consult a veterinarian before using this product on debilitated, aged pregnant or nursing animals. If signs of sensitivity occur, bathe your pet with soap and rinse with large amounts of water. If signs continue, consult a veterinarian immediately.

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Cat

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Paralysis

12. How long did the symptoms last?

Anticip. permanent/Permanence anticipée

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

Yes

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Recvrd resid.effects/Rétabli séquelles

16. How was the animal exposed?

Other / Autre

specify contact with nursing mother who had been treated with product

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

Veterinarian called to report symptoms of 4 week old cat after owner inappropriately applied product to it's nursing mother. Product was applied April 25, 2012 however kitten did not receive veterinarian care until 2 weeks later. Veterinarian received advice including that this product is not to be used on nursing or pregnant cats as kittens can lick some of the product residue off the mother cat from nursing and to bathe mother cat and kitten in dish soap and warm water. Veterinarian was asked for proper product ID info as product name and format are still unknown, making it difficult to give the best treatment advice.


To be determined by Registrant

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

Major

19. Provide supplemental information here

Owner did not follow label directions. Label states: DO NOT USE ON KITTENS LESS THAN 12 WEEKS OLD.Consult a veterinarian before using this product on debilitated, aged pregnant or nursing animals. If signs of sensitivity occur, bathe your pet with soap and rinse with large amounts of water. If signs continue, consult a veterinarian immediately.