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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7261

2. Registrant Information.

Registrant Reference Number: 130124195

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.

04-SEP-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

16-AUG-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. 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

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 15, 2013 the owner sprayed the dog with the product to treat for fleas.

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

Dog / Chien

3. Breed

Cairn Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

20.0

lbs

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

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Bloody vomit
  • General
    • Symptom - Lethargy

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.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Euthanised / Euthanasie

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 the morning of August 16, 2013 the owner noticed that the dog was symptomatic. Later that evening the owner took the dog to the veterinarian, where she was monitored, given intravenous (IV) fluid therapy, and given a diagnostic evaluation that the owner said included bloodwork and X-rays and may have shown evidence of pancreatitis. On August 19, 2013 the dog was euthanized. On September 4, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian recommended that the owner obtain and send additional information about the lab work that was done for the dog and referred the owner to the product's manufacturer. A necropsy was not available because the dog had already been buried.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a low likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected.