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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-0468

2. Registrant Information.

Registrant Reference Number: 070056981

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.

06-JUN-07

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

11-MAY-07

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. 26494      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control for Dogs Under 14 kig

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

PMRA Registration No. 26496      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On 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.

1

Units: mL

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 10, 2007 at 6:00 p.m. CDT, the owner applied the dog product to two dogs--a 2 year old, neutered, female maltese and a 1 year old, neutered, male maltese. At the same time, the owner also applied the cat product to her 15 year old, neutered, female domestic short hair cat. The products were applied dermally to all three animals.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Maltese

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

16

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Muscle weakness
    • Specify - hind limb weakness

12. How long did the symptoms last?

Unknown / Inconnu

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 May 11, 2007 at approximately 8:00 a.m. CDT, the owner noticed the pets were ataxic and having hind limb weakness. She called her regular veterinarian and bathed the pets, per the veterinarian's instructions. June 7th - owner advised APSS all animals recovered without treatment.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS staff told the owner that significant reactions in dogs are uncommon and told the owner about the local reactions at the site of application that are generally expected in sensitive animals.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

15

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

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Muscle weakness
    • Specify - hind limb weakness

12. How long did the symptoms last?

Unknown / Inconnu

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 May 11, 2007 at approximately 8:00 a.m. CDT, the owner noticed the pets were ataxic and having hind limb weakness. She called her regular veterinarian and bathed the pets, per the veterinarian's instructions. June 7th - owner advised APSS all animal recovered without treatment.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS staff told the owner that significant reactions in dogs are uncommon and told the owner about the local reactions at the site of application that are generally expected in sensitive animals.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Maltese

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

8.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Muscle weakness
    • Specify - hind limb weakness

12. How long did the symptoms last?

Unknown / Inconnu

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 May 11, 2007 at approximately 8:00 a.m. CDT, the owner noticed the pets were ataxic and having hind limb weakness. She called her regular veterinarian and bathed the pets, per the veterinarian's instructions. June 7th - owner advised APSS all animals recovered without treatment.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS staff told the owner that significant reactions in dogs are uncommon and told the owner about the local reactions at the site of application that are generally expected in sensitive animals.