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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-0035

2. Registrant Information.

Registrant Reference Number: 090137455

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.

12-DEC-09

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

12-DEC-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. 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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2

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 December 9, 2009 the owner accidentally applied the product to the 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 Mediumhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
    • Symptom - Head shaking

12. How long did the symptoms last?

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

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 December 12, 2009 the APSS veterinarian stated exposure in cats to concentrated permethrins can result in significant central nervous system signs, such as tremors and seizures. She also stated that treatment is symptomatic and the prognosis is good with appropriate medical care. The APSS veterinarian recommended the cat be taken to the veterinarian, have the veterinarian call for information, and call back with questions.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

On December 14, 2009 an APSS technician called the owner to follow up the case. The owner stated that the cat's head shaking had ended on December 13, and she had not taken the cat to the veterinarian as she received advice from a friend who informed her the effects will wear off eventually and that the owner would not have to take the cat to the local veterinarian. The owner also stated that the cat had made a full recovery. This product was not used according to label directions: Do not use on cats.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Mediumhair

4. Number of animals affected

2

5. Sex

Female

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

10

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

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

11. List all symptoms

System

  • General
    • Symptom - Subdued

12. How long did the symptoms last?

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

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 December 12, 2009 the APSS veterinarian stated exposure in cats to concentrated permethrins can result in significant central nervous system (CNS) signs. She also stated that treatment is symptomatic and the prognosis is good with appropriate medical care. The APSS veterinarian recommended bathing the cats with liquid dish washing detergent, monitor the cats at home for CNS signs, take the cats to the veterinarian, have the veterinarian call for information, 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

On December 14, 2009 an APSS technician called the owner to follow up the case. The owner stated that on December 12, she had bathed both cats with liquid dish washing detergent, monitored them at home for central nervous system signs, and provided thermoregulation. She did not take the cats to the veterinarian or have the veterinarian call for information, as it was not needed. The owner also stated that both cats had made a full recovery on December 12, shortly after the baths. this product was not used according to label directions: Do no use on cats.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Medium Hair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

10

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

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

11. List all symptoms

System

  • General
    • Symptom - Subdued

12. How long did the symptoms last?

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

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 December 12, 2009 the APSS veterinarian stated exposure in cats to concentrated permethrins can result in significant central nervous system (CNS) signs. She also stated that treatment is symptomatic and the prognosis is good with appropriate medical care. The APSS veterinarian recommended bathing the cats with liquid dish washing detergent, monitor the cats at home for CNS signs, take the cats to the veterinarian, have the veterinarian call for information, 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

On December 14, 2009 an APSS technician called the owner to follow up the case. The owner stated that on December 12, she had bathed both cats with liquid dish washing detergent, monitored them at home for central nervous system signs, and provided thermoregulation. She did not take the cats to the veterinarian or have the veterinarian call for information, as it was not needed. The owner also stated that both cats had made a full recovery on December 12, shortly after the baths. this product was not used according to label directions: Do no use on cats.