Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-3427

2. Registrant Information.

Registrant Reference Number: 120040298

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-12

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

30-MAR-12

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)

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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 %

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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 29, 2012 the owner sprayed the puppy with the product.

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

Canine Domestic Unspecified Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.50

7. Weight (provide a range if necessary )

35.0

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 - Anorexia
  • Symptom - Vomiting
  • Symptom - Diarrhea
  • Symptom - Other
  • Specify - Hemorrhagic Gastroenteritis

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Unknown

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 March 30, 2012 the owner noticed that the puppy was anorexic, vomiting, had diarrhea, and had hemorrhagic gastroenteritis. On the morning of April 2, 2012 the owner took the puppy to the veterinarian, where a parvovirus test was performed; the results of that test came back negative. About an hour later, the puppy died. Later that day, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that with therapeutic use of the product per label, significant signs would not be expected. The APSS veterinarian also stated that, if ingested, the product could cause mild gatrointestinal (GI) upset, and that the signs seemed more consistent with parvovirus. The owner did not wish to pursue a necropsy. The APSS veterinarian referred the owner to the product manufacturer per request.

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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 and that parvovirus was considered to have a medium likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected.