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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-2901

2. Registrant Information.

Registrant Reference Number: 1-40049409

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.

25-MAR-15

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

14-MAR-15

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. 25695      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Premise 2000 Flea Spray ( Canadian)

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

7. b) Type of formulation.

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).

Caller used this product in his trailer on March 14.

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

  • Eye
    • Symptom - Other
    • Specify - Poor depth perception
  • General
    • Symptom - Lightheadedness
  • Gastrointestinal System
    • Symptom - Mouth Irritation
    • Symptom - Nausea
  • General
    • Symptom - Drowsiness
  • Nervous and Muscular Systems
    • Symptom - Confusion
    • Symptom - Dizziness

4. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

Yes

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

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

Application

Contact with treated area

Amount of time between application and contact 4

Hour(s) / Heure(s)

What was the activity? Inhalation

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.

Respiratory

11. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

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.)

Within 10 minutes of application, he got dizzy and his depth perception became poor. The employee from the feed store where it was purchased recommended waiting 4-5 hours before returning to the trailer. He left the trailer and removed all the bedding and did laundry. After leaving he felt better, he was not dizzy, his vision was ok, although his head felt fuzzy and he had a burning sensation on his tongue and lips. 6 hours after treatment he returned to the trailer and within 30 minutes the symptoms returned. He slept in a hotel that night. The following day he did not feel better and slept in a hotel again. On March 16 he arranged for a steam cleaning which was performed on March 19. He did not return to the trailer until after it was steam cleaned. He did notice that the underside of the bed was not cleaned as it had a strong odor. His symptoms appeared again after the steam cleaning was performed. He slept in the trailer that night and the following night. The morning of the 21st he awoke feeling groggy and his stomach felt poorly. He stayed in a hotel again that night.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

On the 22nd he went to the ER and brought the can with him. The doctor took blood samples and phoned poison control. The doctor said he may be sensitive to chemicals in the can and recommended he stop using it. He stayed in the trailer that night and was not as uncomfortable. Monday night he also stayed in the trailer and Tuesday morning he did not feel good again and removed his bedding and put it into his truck and left the trailer. The patient should be removed from the source of the fumes and placed in an area with fresh air and adequate ventilation. Seek medical attention if symptoms do not resolve within the next 30 minutes. Recommend avoiding using the product in the future in case he has a sensitivity. Recommend not staying in the home until additional cleaning can be performed - Recommend getting medical attention due to ongoing symptoms, also recommend consider other causes- would not expect vision difficulties, etc or for symptoms to persist Concentration of AI in product is very low - Dermal contact with the product would not be expected to cause systemic toxicity. Reiterated importance of getting medical attention as there may be something else going on leading to his symptoms.