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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-0571

2. Registrant Information.

Registrant Reference Number: 090138404

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.

14-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. 26413      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Double Action Flea and Tick Shampoo

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

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 December 10, 2009 the owner inappropriately bathed the under aged kittens with the shampoo.

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 )

0.01

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

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Recumbent
    • Specify - Lateral Recumbency
  • Gastrointestinal System
    • Symptom - Diarrhea

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 kitten had diarrhea and was laterally recumbent, so the owner gave the kitten water. On the morning of December 13, 2009 the kitten was no longer laterally recumbent but became so again that evening. On December 14, 2009 the APSS technician stated the signs and time frame were not consistent with signs expected from the shampoo. The APSS technician recommended the owner take the kitten to the veterinarian, have the veterinarian call for information, supplement food with kitten milk replacer, and rub karo syrup on the kitten's gums if the kitten became limp again.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

On December 16, 2009 an APSS assistant contacted the owner to follow up the case. The owner stated the kitten's lateral recumbency ended after the APSS consultation, and the diarrhea ended on December 15, 2009. The owner also stated she had given the kitten milk replacer but had not taken her to the veterinarian or given her karo syrup. The kitten had fully recovered on December 15, 2009. The APSS veterinarian stated the substance was not considered to be related to causing the clinical signs. This product was not used according to label directions: Do not use on kittens under 12 weeks of age.

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 )

0.01

7. Weight (provide a range if necessary )

Unknown

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

  • Gastrointestinal System
    • Symptom - Diarrhea
  • 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

On December 14, 2009 the APSS technician stated the signs and time frame are not consistent signs expected from the shampoo. The APSS technician recommended the owner take the kitten to the veterinarian, have the veterinarian call for information, supplement food with kitten milk replacer, and rub karo syrup on the kitten's gums if the kitten becomes limp.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. On December 16, 2009 an APSS assistant contacted the owner to follow up the case. The owner stated she had not given the kitten milk replacer or karo syrup and had not taken her to the veterinarian. The owner also stated that the kitten had died on December 15, 2009. This product was not used according to label directions: do not use on kittens under 12 weeks of age.