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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-0189

2. Registrant Information.

Registrant Reference Number: 090098763

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.

01-SEP-09

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-JUN-09

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. 26496      PMRA Submission No.       EPA Registration No.

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

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

PMRA Registration No. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control For Dogs Over 14 kg

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

PMRA Registration No. 26494      PMRA Submission No.       EPA Registration No.

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

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

7. b) Type of formulation.

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).

On July 1, 2009 the pet owner applied the wrong dose of 1/2 ml of the Zodiac Spot On Flea Control for Cats and Kittens to three cats in her household. On June 1, 2009 and September 1, 2009 the pet owner applied the wrong dose of 2 ml of the Zodiac Fleatrol Power Spot Flea and Tick Control For Dogs Under 14 kg to her 23 pound dog. On June 1, 2009 and September 1, 2009 the pet owner applied 2.0 mL of the Zodiac Fleatrol Power Spot Flea and Tick Control For Dogs Over 14 kg to her 28 pound dog.

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

Himalayan

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

4.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Burns (superficial)

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 July 3, 2009 the owner bathed the cat twice, once with cold water. On July 11, 2009 the cat made a full recovery. On September 1, 2009 the pet owner contacted the Animal Product Safety Service (APSS) to ask if she should use the product again. The APSS veterinarian stated that there is a concern for a dermal hypersensitivity reaction with this exposure. She recommended that the pet owner discontinue use of the product, discuss other flea prevention methods with her veterinarian, contact the manufacturer to discuss concerns about the product label, and call back with questions.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

The pioduct was not used according to label directions; inappropriate dose.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

23

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Hyperactivity
    • Symptom - Vocalizing

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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 September 1, 2009 the pet owner bathed the dogs with cool water to treat symptoms. The APSS veterinarian recommended that the pet owner bathe the dogs with liquid dish soap, apply vitamin E oil to the application site, call her veterinarian to discuss other flea control options, contact the manufacturer with concerns regarding the product packaging, and call back with questions.


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 high likelihood of causing the clinical situation. Multiple attempts to update the case were unsuccessful; therefore, the outcome is unknown. The product was not used according to label directions: inappropriate dose used.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Himalayan

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

6

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Rash

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

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 July 3, 2009 the owner bathed the cats twice, once with cold water. On July 9, 2009 the cats made a full recovery. The APSS veterinarian recommended that the pet owner discontinue use of the product, discuss other flea prevention methods with her veterinarian, contact the manufacturer to discuss concerns about the product label, and call back with questions.


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 high likelihood of causing the clinical situation. The product was not used according to label directions: inappropriate dose used.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Miniature American Eskimo

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

28

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Hyperactivity
    • Symptom - Vocalizing

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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 September 1, 2009 the pet owner bathed the dogs with cool water to treat symptoms. The APSS veterinarian recommended that the pet owner bathe the dogs with liquid dish soap, apply vitamin E oil to the application site, call her veterinarian to discuss other flea control options, contact the manufacturer with concerns regarding the product packaging, and call back with questions.


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 high likelihood of causing the clinical situation. Multiple attempts to update the case were unsuccessful; therefore, the outcome is unknown. The product was not used according to label directions: inappropriate dose used.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Himalayan

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

7

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Rash

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

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 July 3,2009 the owner bathed the cats twice, once with cold water. On July 9,2009 the cats made a full recovery. The APSS veterinarian recommended that the pet owner discontinue use of the product, discuss other flea prevention methods with her veterinarian, contact the manufacturer to discuss concerns about the product label, and call back with questions.


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 high likelihood of causing the clinical situation. The product was not used according to label directions: inappropriate dose used.