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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6453

2. Registrant Information.

Registrant Reference Number: 130100147

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.

20-JUL-13

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

19-JUL-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. 2724-462-270

Product Name: Adams Flea And Tick Mist For Cats With Precor

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .1 %
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration .62 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .37 %
    • PYRETHRINS
      • Guarantee/concentration .2 %

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).

On July 19, 2013 the owner inappropiately applied the product to his hands and then rubbed the product on the kitten.

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 Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.27

7. Weight (provide a range if necessary )

2.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • 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.

Unknown

14. a) Was the animal hospitalized?

Unknown

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 July 19, 2013 the owner noticed that the kitten was ataxic. Early on the morning of July 20, 2013 the owner noticed that the kitten was lethargic. Later that morning the owner observed that the kitten died. That afternoon the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that if there were pre-existing conditions such as anemia, the kitten may have been more susceptible to adverse effects; death would not be expected following per label use of the product on a healthy cat. A necropsy was not available because the kitten's body had been buried.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Unknown likelihood of causing the clinical situation. Extra label use: product not applied as per label use.