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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-5568

2. Registrant Information.

Registrant Reference Number: 100114925

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.

01-SEP-10

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW JERSEY

6. Date incident was first observed.

01-SEP-10

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. 2724-485-270

Product Name: Farnam Bio Spot Shampoo for Dogs and Puppies

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .1 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 1.5 %
    • PYRETHRINS
      • Guarantee/concentration .15 %

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 September 1, 2010 the owner was bathing the dog with the product, when the dog licked up some of the soapy water.

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

Shih Tzu

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.33

7. Weight (provide a range if necessary )

8

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • Respiratory System
    • Symptom - Panting
    • Symptom - Dyspnea
    • Symptom - Pulmonary edema
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Yes

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 September 1, 2010 the dog began to vomit immediately after licking the product and then started to pant. The owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian recommended the owner take the dog to the veterinarian and have the veterinarian call for information. The owner was reluctant to take the pet to the emergency clinic, so the APSS veterinarian recommended the owner monitor the the dog at home for respiratory signs, manage the pet's vomiting, and call back if the respiratory signs do no resolve in the next hour or get worse.


To be determined by Registrant

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

Death

19. Provide supplemental information here

After the APSS consultation, on September 1, 2010, the dog began experiencing dyspnea, so the owner called the APSS back. The APSS veterinarian again recommended the owner take the pet to the veterinarian to be examined. The owner took the dog to the veterinarian, who recommended the owner contact the APCC. The owner called the APSS, the APSS veterinarian recommended the owner have the attending veterinarian examine the pet and call back. On September 4, 2010 an APSS assistant called the owner to follow up the case. The owner stated at the veterinary clinic, the dog was put on oxygen and the attending veterinarian diagnosed him with fluid in his lungs. The owner stated the dog had died the next day, September 2, 2010, and the body was cremated. The owner did not have additional questions.