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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-5685

2. Registrant Information.

Registrant Reference Number: 1-26009087

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.

30-APR-11

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

28-APR-11

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. 2724-734-2596

Product Name: Hartz UltraGuard 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.

4

Other Units: drops

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 applied to cat on April 26th or April 27th, 2011.

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

Other

2. Type of animal affected

Cat / Chat

3. Breed

Cat Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
  • Eye
    • Symptom - Pupil dilation
  • Gastrointestinal System
    • Symptom - Vomiting
  • 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?

Treatment / Traitement

17. Provide any additional details about the incident

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

On April 28th, 2011 cat was symptomatic. On April 29th, 2011 cat was drinking some water. On April 30th, 2011 cat had dilated pupils and having problems walking, caller thinks he may have HBC and he has not had any vaccinations, it is important to note that this cat was an outdoor feral cat. Caller was told when applied as directed the product has low level of toxicity and wide margin of safety even if some of the drops may have been licked while grooming himself.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The cat died about 10 minutes after talking to (name) and (name) on April 30th, 2011. There was evidence of bite marks near the cat's ears and back over the last several weeks. Per company veterinarian, the product was determined doubtfully related.