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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7221

2. Registrant Information.

Registrant Reference Number: 130091762

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.

05-JUL-13

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

04-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. 26413      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Double Action Flea And Tick Shampoo For Dogs And Cats

  • 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 July 1, 2013 the owner bathed the dog with the shampoo product to prevent 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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.0

7. Weight (provide a range if necessary )

6.5

lbs

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

  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Lethargy
    • Symptom - Hypothermia
  • Gastrointestinal System
    • Symptom - Diarrhea

12. How long did the symptoms last?

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

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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 4, 2013 the owner noticed that the dog was vomiting. On July 5, 2013 the owner took the dog to an emergency veterinarian, who observed that the dog was lethargic, hypothermic with a temperature of 99.0 degrees Fahrenheit, and having loose stools with mucus. That evening the emergency veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the shampoo's active ingredients are of a low concentration and are usually rinsed off with routine bathing, with minimal residual material remaining. The APSS veterinarian also stated that ingestion of the product could cause vomiting and diarrhea, but these signs would be expected to occur within a few hours of ingestion. The APSS veterinarian recommended that the emergency veterinarian have a complete blood count and chemistry profile done, monitor the dog's electrolytes, provide fluid therapy, provide thermoregulation, provide symptomatic and supportive care, obtain additional information about other agents used on the dog or other toxins in the immediate environment, and call back with questions.


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 doubtful likelihood of causing the clinical situation. On July 10, 2013 the emergency veterinarian contacted the APSS to update the case. The emergency veterinarian stated that on July 5, 2013 the dog was given subcutaneous fluids and a dose of Cerenia, and Metronidazole was prescribed. The owner did not want to hospitalize the dog, and the owner brought the dog back to the emergency veterinarian on July 6, 2013 for a re-check. The emergency veterinarian stated that the owners informed him that the dog had fully recovered on July 9, 2013.