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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4416

2. Registrant Information.

Registrant Reference Number: 130057237

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.

03-MAY-13

5. Location of incident.

Country: UNITED STATES

Prov / State: SOUTH CAROLINA

6. Date incident was first observed.

19-APR-13

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.       PMRA Submission No.       EPA Registration No. 2724-488

Product Name: Zodiac Spot On Flea Control For Cats And Kittens

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %

7. b) Type of formulation.

Liquid

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).

Around April 17, 2013 the owner applied an unknown amount of the product to 5 kittens to treat for fleas. About a week later, on April 24, 2013, the owner reapplied the product to all 5 kittens and also applied the product to another group of 3 kittens to treat for fleas.

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

Feline Domestic Unspecified

4. Number of animals affected

4

5. Sex

Unknown

6. Age (provide a range if necessary )

0.26

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

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

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

On April 24, 2013 the owner noticed that the 4 kittens were lethargic. On April 30, 2013 the owner observed that all 4 kittens had died. On May 3, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian discussed that this is an insect growth regulator and will not kill adult fleas. Some cats will have dermal reactions but the kittens' signs would not be expected with minor doses, even though used off label, especially with signs developing a day or so later. A necropsy was not available.


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 considered to have a doubtful likelihood of causing the clinical situation. Suspected cause of death was flea bite anemia. Owner did not dose according to label.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Feline Domestic Unspecified

4. Number of animals affected

3

5. Sex

Unknown

6. Age (provide a range if necessary )

0.24

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

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Abnormal behaviour
    • Specify - Behavior Change
    • 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 April 24, 2013 the owner noticed that the 3 kittens had a behavior change immediately after the product had been applied. On April 30, 2013 the owner observed that all 3 kittens had died. On May 3, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that there was a low risk for dermal hypersensitivity for the kittens given the exposure history. A necropsy was not available.


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 considered to have a doubtful likelihood of causing the clinical situation. Suspected cause of death flea anemia. Owner did not dose according to label.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Feline Domestic Unspecified

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.26

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

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 - Ataxia
  • 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 April 19, 2013 the owner noticed that the kitten was symptomatic. On April 30, 2013 the owner observed that the kitten had died. On May 3, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that there was a low risk for dermal hypersensitivity for the kitten given the exposure history. A necropsy was not available.


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 considered to have a doubtful likelihood of causing the clinical situation. Suspected cause of death flea anemia. Owner did not dose according to label.