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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0826

2. Registrant Information.

Registrant Reference Number: 100072841

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G5L3

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

08-JUN-10

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

18-MAY-10

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. 28743      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On II Flea Control for Cats and Kittens

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

3

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).

On May 18, 2010 the owner applied the product onto each of the five cats.

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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

8

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Agitation
  • Skin
    • Symptom - Lesion
    • Specify - Ulceration

12. How long did the symptoms last?

Unknown / Inconnu

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

Not recovered / Non rétabli

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 May 18, 2010 the cat became agitated and the owner noticed the application area had become ulcerated. The owner then gave the cat a bath and treated her with a salt water bath and an unknown cream. On July 7, 2010 the owner took the cat to the veterinarian as the ulceration had become larger. The attending veterinarian prescribed topical medications, a corticosteroid and ozonol ointment. On June 8, 2010 the APSS veterinarian stated neurotoxicity is not expected. The APSS technician relayed the APSS veterinarian's recommendations to call back with questions, obtain additional information, and call the manufacturer to discuss reimbursement and analysis of applied tube.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

On June 11, 2010 an APSS veterinarian called the owner to follow up the case. The owner stated the cat's skin ulcer still had not healed. The APSS veterinarian recommended taking the cat back to the attending veterinarian to have the wound reassessed, and discontinuing the ozonol ointment.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Feline Domestic Unspecified

4. Number of animals affected

4

5. Sex

Male

Female

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Agitation

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

Fully Recovered / Complètement rétabli

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 June 8, 2010 the APSS veterinarian stated neurotoxicity is not expected. The APSS technician relayed the APSS veterinarian's recommendations to call back with questions and obtain additional information.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a medium likelihood of causing the clinical situation. On June 11, 2010 an APSS veterinarian called the owner to follow up the case. The owner stated the cats had fully recovered.