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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-2850

2. Registrant Information.

Registrant Reference Number: 130041460

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.

02-APR-13

5. Location of incident.

Country: UNITED STATES

Prov / State: OREGON

6. Date incident was first observed.

19-MAR-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.       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: 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 March 19, 2013 the owner applied the product to the dog 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

Yorkshire Terrier Mix

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 )

3.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Head tilt
  • General
    • Symptom - Hyperthermia
  • 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.

No

14. a) Was the animal hospitalized?

No

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 March 19, 2013 the owner noticed that the dog was vomiting, having diarrhea, and was ataxic. At an unknown time that evening, the owner observed that the dog was hyperthermic, with a temperature recorded as 104.0 degrees Fahrenheit, and his head was tilted. Later that evening, the owner noticed that the dog had a seizure and the dog died soon after. On April 2, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that death or seizures would not be expected. The APSS veterinarian also stated that ataxia could be seen with overspraying, but that did not appear to be the case in this situation. The owner stated that she had already buried the dog, so a necropsy was not available.


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 not considered to be related to the clinical situation.