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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0079

2. Registrant Information.

Registrant Reference Number: 1-49478644

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.

25-AUG-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

Unknown

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. 23075      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Premise Plus 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: 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 sprayed the product in her house on the carpets, molding, rugs and furniture about three weeks before the call date.

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: Female

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

3. List all symptoms, using the selections below.

System

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

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.

Unknown

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Unknown

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

Application

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?

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

12. Time between exposure and onset of symptoms.

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

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 sprayed the house three weeks ago. She developed an allergic reaction to the product she thinks that she used three weeks ago. She has had her carpets and rugs cleaned professionally, but not her furniture she sprayed it on. She is now taking oral Benedryl and Clariton. The Propharma agent stated that skin exposure may cause a burning, itching, tingling, or numbness sensation. Symptoms typically develop soon after the exposure and resolve spontaneously within 24 hours. If symptoms develop, you may apply a light coating of vitamin E oil every four hours as needed, it may help reduce the intensity and duration of the sensation. The agent also stated that the product may irritate the eyes but it is not corrosive or expected to cause corneal burns. Since symptoms have persisted passed any expected time with the product, the caller should seek medical attention and to call back with any questions on concerns.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

Signs were expected to be mild and self-limiting. No additional information was expected.