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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6947

2. Registrant Information.

Registrant Reference Number: 1-54609314

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: N1G 5L3

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

Human

4. Date registrant was first informed of the incident.

08-NOV-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

06-NOV-18

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

  • 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: Other / Autre

Préciser le type: In Truck

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

Caller reported that after he sprayed the product in his truck on November 6th, 2018, he developed symptoms.

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

  • Respiratory System
    • Symptom - Shortness of breath
  • Cardiovascular System
    • Symptom - Abnormally fast heart rate
  • Nervous and Muscular Systems
    • Symptom - Muscle pain
    • Specify - Myalgia

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.

Unknown

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

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

Respirator

10. Route(s) of exposure.

Respiratory

11. What was the length of exposure?

Unknown / Inconnu

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.)

On November 8th, 2018, the caller reported he sprayed the product two days prior in his truck due to a flea infestation. He said he could have inhaled some of the vapors in the process but stated he was using a NIOSH respirator most of the time. Approximately 24 hours later after spraying, he developed symptoms that had persisted until he called in. He said he has an appointment with his physician the day of calling and wanted to know if these signs are typical. The call center staff stated that the product can cause respiratory irritation with inhalation exposure however, they would expect these signs to develop shortly after the exposure and resolve within 30 to 60 minutes of leaving the treated area. The delayed onset, duration and persistence of his signs would not be typical with the exposure he had described. The call center staff agent also stated that additionally, while people with asthma may have more severe respiratory irritation, the reported signs of myalgia and possibly increased HR would not be expected with this product. Finally the call center staff agent agreed that the caller should be seen by his physician, if signs were to worsen, particularly worsen dyspnea, he should call 911 for immediate assistance and to have his physician contact if any further information would be needed.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.