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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-2899

2. Registrant Information.

Registrant Reference Number: 1-39060466

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.

20-NOV-14

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

20-NOV-14

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. 2724-483

Product Name: Zodiac carpet and upholstery aerosol spray

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Unknown
    • PERMETHRIN
      • Unknown

7. b) Type of formulation.

Other (specify)

aerosol

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).

Product was applied on 11/19/2014 for flea infestation.

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: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

  • Cardiovascular System
    • Symptom - Arrhythmia
    • Specify - Atrial Fibrillation, dysrhythmia

4. How long did the symptoms last?

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

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

Unknown

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)

Chemical resistant gloves

10. Route(s) of exposure.

Respiratory

11. What was the length of exposure?

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

12. Time between exposure and onset of symptoms.

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

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 (a (age) year old male) states that he sprayed this product yesterday morning and during application he had the windows open, he wore a dust mask and he had gloves on. He used the can in 12x14 foot room. He could smell it while he was applying the product but he left the room after he finished applying the product and was in fresh air for the rest of the day. He was feeling fine after the exposure but then at 5 am he woke up and was symptomatic. He called an ambulance and is currently in the hospital. He has been diagnosed with atrial fibrillation. The caller states that he has never had any heart issues his entire life and this is the only thing new that was introduced. Caller is wondering if symptoms are from exposure to this product.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Symptoms are not consistent with product exposure.