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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-4090

2. Registrant Information.

Registrant Reference Number: 090094749

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.

22-AUG-09

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

20-AUG-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. 21744      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Flea and Tick Spray for Dogs and Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

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. 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 August 19, 2009 the pet owner used all three products on the cats to treat a flea infestation.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

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 )

1

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

  • General
    • Symptom - Lethargy
  • Renal System
    • Symptom - Inappropriate urination
    • Specify - Inappropriate Urination
  • Gastrointestinal System
    • Symptom - Inappropriate defecation
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
    • Symptom - Hiding

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

The APSS veterinarian stated that the exposure to the Zodiac Fleatrol Flea and Tick Spray for Dogs and Cats would not be expected to cause serious problems but that alcohol intoxication would be possible if the pet were oversprayed. The APSS veterinarian stated that a dermal reaction can occur with an exposure to the Zodiac Spot On Flea Control for Cats but that the cat's current symptoms would not be expected. The APSS veterinarian stated that serious problems would not be expected with an exposure to the Zodiac Fleatrol Double Action Flea and Tick Shampoo. She recommended that the pet owner take the cat to the veterinarian and have the veterinarian call for information. The pet owner was reluctant to take the cat to the veterinarian. The APSS veterinarian also recommended that the pet owner bathe the cat and keep her warm following the bath, offer a soft meal, 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

According to APSS the clinical signs were not likely related to the use of the products. The outcome of this case is unknown.

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

Unknown

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?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
    • 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

The APSS veterinarian stated that the exposure to the Zodiac Fleatrol Flea and Tick Spray for Dogs and Cats would not be expected to cause serious problems but that alcohol intoxication would be possible if the pet were oversprayed. The APSS veterinarian stated that a dermal reaction can occur with an exposure to the Zodiac Spot On Flea Control for Cats but that sever lethargy and death would not be expected. The APSS veterinarian stated that serious problems would not be expected with an exposure to the Zodiac Fleatrol Double Action Flea and Tick Shampoo. She recommended a necropsy to determine the cause of death, and the owner declined.


To be determined by Registrant

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

Death

19. Provide supplemental information here

According to APSS the clinical signs were not likely related to the use of the products. The outcome of this case is unknown.

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

Male

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?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
    • 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

The APSS veterinarian stated that the exposure to the Zodiac Fleatrol Flea and Tick Spray for Dogs and Cats would not be expected to cause serious problems, but that alcohol intoxication would be possible if the pet were oversprayed. The APSS veterinarian stated that a dermal reaction can occur with an exposure to the Zodiac Spot On Flea Control for Cats, but that sever lethargy and death would not be expected. The APSS veterinarian stated that serious problems would not be expected with an exposure to the Zodiac Fleatrol Double Action Flea and Tick Shampoo. She recommended a necropsy to determine the cause of death, and the owner declined.


To be determined by Registrant

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

Death

19. Provide supplemental information here

According to APSS the clinical signs were not likely related to the use of the products. The outcome of this case is unknown.