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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-5693

2. Registrant Information.

Registrant Reference Number: 1-263251

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.

25-MAY-11

5. Location of incident.

Country: UNITED STATES

Prov / State: MARYLAND

6. Date incident was first observed.

Unknown

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

  • 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.

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 applied to cats on May 17th, 2011.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

not known

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

29

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

  • Renal System
    • Symptom - Other
    • Specify - unable to urinate
  • 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

Product was applied on May 17th, 2011. Cats became symptomatic however date this was observed is unknown. Cat died on May 22nd, 2011.


To be determined by Registrant

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

Death

19. Provide supplemental information here

There is little information provided, owner suspected kidney failure but did not seek veterinary care. The cat was buried therefore necropsy was not performed. It is unknown exactly which product was used as package was thrown away therefore unclear if proper dosage or product was used. A necropsy can not be performed therefore it is not possible to determine cause of symptoms and death. Per company veterinarian, product was determined doubtfully related.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

11

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

  • Renal System
    • Symptom - Other
    • Specify - unable to urinate
  • General
    • Symptom - Death

12. How long did the symptoms last?

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

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

Product was applied on May 17th, 2011. Cats became symptomatic however date this was observed is unknown. Cat died on May 22nd, 2011.


To be determined by Registrant

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

Death

19. Provide supplemental information here

There is little information provided, owner suspected kidney failure but did not seek veterinary care. The cat was buried therefore necropsy was not performed. It is unknown exactly which product was used as package was thrown away therefore unclear if proper dosage or product was used. A necropsy can not be performed therefore it is not possible to determine cause of symptoms or death. Per company veterinarian, product was determined doubtfully related.