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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1401

2. Registrant Information.

Registrant Reference Number: 1-31809283

Registrant Name (Full Legal Name no abbreviations): WELLMARK INTERNATIONAL

Address: 100 STONE ROAD WEST, SUITE 111

City: GUELPH

Prov / State: ON

Country: CANADA

Postal Code: N1G 5L3

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

16-OCT-12

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

02-SEP-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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-462-270

Product Name: Adams Flea and Tick Mist for Cats with Precor

  • 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).

Caller's husband was using product over a period of a couple of months. Caller is unsure of exact date of use.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Male

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Weight loss
  • Skin
    • Symptom - Pruritus
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - can not lay down
    • Symptom - Insomnia
  • Liver
    • Symptom - Hyperbilirubinemia
    • Specify - bilirubin increase
    • Symptom - Hepatic failure
    • Specify - failure/dysfunction
  • Skin
    • Symptom - Discolouration
    • Specify - color alteration
  • Liver
    • Symptom - Other
    • Specify - gallstones

4. How long did the symptoms last?

>1 mo and <= 2mos / >1 mois et < = 2mois

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

Yes

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Application

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

None

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

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

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

Caller's husband was using the product over a period of a couple of months, caller believes he became symptomatic around September 2nd 2012. He has been seen by a doctor and treated for gall stones and some gall stones were removed. His bilirubin was 27.7 and after removal of gall stones increased to 37. He has had CT's and MRIs of his liver. It seems fine. A liver biopsy was done, no results provided. Blood work was done but could not determine what was wrong with him. Doctor stated his condition may be related to his supplements (fish oil, vitamin d, multiple vitamin, Coenzyme Q10) or his new cholesterol medication.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Symptoms determined by poison control to be doubtfully related to the product.