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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3844

2. Registrant Information.

Registrant Reference Number: 1-25633946

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.

18-MAR-11

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

18-JUL-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. 2724-777-2596

Product Name: Hartz Advanced Care 3 in 1 Carpet Powder

  • Active Ingredient(s)
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .5 %
    • PYRETHRINS
      • Guarantee/concentration .075 %
    • PYRIPROXYFEN
      • Guarantee/concentration .02 %

7. b) Type of formulation.

Dust

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Res. - In Home / Rés. - à l'int. maison

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

On July 18th, 2010 product was applied in the home.

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.

Data Subject

2. Demographic information of data subject

Sex: Male

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

3. List all symptoms, using the selections below.

System

  • General
    • Symptom - Swelling
  • Gastrointestinal System
    • Symptom - Diarrhea
  • Respiratory System
    • Symptom - Irritated throat
  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Joint pain
    • Symptom - Other
    • Specify - swollen glands
  • Nervous and Muscular Systems
    • Symptom - Headache
  • Eye
    • Symptom - Irritated eye

4. How long did the symptoms last?

>2 mos and <=6mos />2 mois et <=6mois

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

Unknown

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)

Contact with treated area

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

Unknown

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

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

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.)

Product was applied to home on July 18th, 2011. 2 months later husband became symptomatic. Symtoms continue.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

The symptoms described are not expected from the use of the product when label directions are followed. Case number was given to caller to give to her doctor so that he could be provided with further information.

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

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Female

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

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Pruritus
  • General
    • Symptom - Swelling
  • Gastrointestinal System
    • Symptom - Diarrhea
  • Respiratory System
    • Symptom - Irritated throat
  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Joint pain
    • Symptom - Other
    • Specify - swollen glands
  • Nervous and Muscular Systems
    • Symptom - Headache
  • Eye
    • Symptom - Irritated eye

4. How long did the symptoms last?

>6 mos / > 6 mois

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)

Unknown

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>24 hrs <=3 days / >24 h <=3 jours

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.)

On July 18th, 2010 caller became symptomatic. Caller stated symptoms continued and went to see her doctor. Tests were performed but her doctor was unable to diagnose her symptoms.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Caller was told the symptoms described are not expected with normal use of the product when label directions are followed. Case number was given to caller to give to her doctor so that he could be provided with further information.

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

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Female

Age: >12 <=19 yrs / >12 <=19 ans

3. List all symptoms, using the selections below.

System

  • Nervous and Muscular Systems
    • Symptom - Numbness
  • Gastrointestinal System
    • Symptom - Stomach pain
    • Symptom - Nausea
  • Nervous and Muscular Systems
    • Symptom - Muscle twitching
    • Specify - twitching limbs
  • Eye
    • Symptom - Irritated eye
    • Symptom - Conjunctivitis

4. How long did the symptoms last?

>2 mos and <=6mos />2 mois et <=6mois

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)

Contact with treated area

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

Unknown

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

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 stated her daughter became symptomatic after product was applied on July 17, 2011. The date was not specified when symptoms started. Daughter was seen by doctor for symptoms and was treated for pink eye for 2 months, caller explained that they figured out that is not what she had.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Caller was told the symptoms described are not expected with normal use of the product when label directions are followed. Case number was given to caller to give to her doctor so that he could be provided with further information.