Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4404

2. Registrant Information.

Registrant Reference Number: 130065623

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.

19-MAY-13

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

18-MAY-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-404

Product Name: Vet Kem Ovitrol Plus Flea Tick and Bot Spray

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .27 %
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • Guarantee/concentration .62 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration .37 %
  • PYRETHRINS
    • Guarantee/concentration .2 %

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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 May 10, 2013 the owner used straight vinegar and Listerine to try to treat the kitten's fleas. On May 15, 2013 the owner sprayed the product on a towel and wrapped the under labelled aged kitten in it to treat the flea infestation.

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 Longhair Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.12

7. Weight (provide a range if necessary )

2.0

lbs

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

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Adipsia
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Weight loss

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Shaking
  • Specify - paw shaking
  • Symptom - Muscle twitching
  • Specify - ear flicking

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 May 18, 2013 the owner noticed that the kitten was symptomatic. Later that day, the owner observed that the kitten died. On May 19, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that paw shaking and ear flicking could be seen in sensitive kittens and that if the product were applied heavily, the alcohol could cause central nervous system (CNS) depression, ataxia, and hypothermia, although these symptoms would probably not be likely with the towel application method.

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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. A necropsy was not available. Owner previously treated with straight vinegar and listerine. Infectious disease distemper or dehydration suspected to be related to symptoms. Off label use on kitten under 12 weeks of age.