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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-5688

2. Registrant Information.

Registrant Reference Number: 110083729

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.

03-JUL-11

5. Location of incident.

Country: UNITED STATES

Prov / State: KENTUCKY

6. Date incident was first observed.

03-JUL-11

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 With Precor Use Only On Dogs Puppies Cats

  • 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: Other / Autre

Préciser le type: Animal and Residential - Inside Home

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On July 2, 2011 the owner sprayed the couch and 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?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Boxer

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.0

7. Weight (provide a range if necessary )

45.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Eye
    • Symptom - Bloodshot eye
    • Symptom - Edema
  • Nervous and Muscular Systems
    • Symptom - Abnormal gait
    • Specify - Unsteadiness
  • Gastrointestinal System
    • Symptom - Drooling
  • General
    • Symptom - Abnormal behaviour
    • Specify - Circling
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • 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 July 3, 2011 the owner noticed the dog was symptomatic. Later that morning, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the ingredients in the product have a wide margin of safety in dogs and that significant signs were not expected. The APSS veterinarian also stated that drooling could occur as a taste reaction, but the other signs the dog was showing would not be expected. The APSS assistant recommended that the owner take the dog to the veterinarian, have the veterinarian call for information, and call back with questions.


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. On August 31, 2011 the owner called the APSS to update the case. The owner stated that at an unknown date and time she took the dog to the veterinarian, where a diagnostic evaluation was performed and the dog was given a Corticosteroid. The owner stated that the dog died on August 20, 2011.