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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6039

2. Registrant Information.

Registrant Reference Number: 1-58533894

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.

11-OCT-19

5. Location of incident.

Country: CANADA

Prov / State: UNKNOWN

6. Date incident was first observed.

11-OCT-19

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. 25739      PMRA Submission No.       EPA Registration No.

Product Name: VetKem Siphotrol 1000 Double Action Premise

  • 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).

On October 11th the caller used the product inside the home alternating with vacuuming. She got some of the product on her hand while spraying upholstery and the carpet.

To be determined by Registrant

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

No

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: Female

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

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Irritated skin
  • Eye
    • Symptom - Irritated eye

4. How long did the symptoms last?

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

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

No

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)

Unknown

10. Route(s) of exposure.

Skin

Eye

11. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

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.)

During the application of this product alternating with vacuuming, the caller got the product onto her skin. She reported symptoms and also mentioned eye irritation before the product was used that day, she stated it was worse after application. She washed the area of her skin that was exposed to the product. The call center staff stated that this product contains a pyrethroid insecticide and can cause a burning, itching, tingling sensation and that typically symptoms develop soon after the exposure and resolve spontaneously within 24 hours. The call center staff said to consult a healthcare professional if symptoms persist for more than 24 hours and that inhalation of this product may lead to irritation of the eyes, and that she ventilate the area with fresh air and leave the area where the product was applied.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

This was off label use. After the area has been treated it should be vacated and left to dry before re-entry. Signs were expected to be mild and self-limiting.