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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6944

2. Registrant Information.

Registrant Reference Number: 1-53888781

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.

06-SEP-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

06-SEP-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: 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: 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 September 6th 2018 the caller sprayed the product inside her home.

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 - Paresthesia
    • Symptom - Burning skin

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

Unknown

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

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.)

Two hours after using the product, the caller called the call center to report a burning sensation in her arms. She noticed this symptom about 15 - 30 minutes after treating inside her home, she believes some of the over spray came back onto her skin so she washed with soap and had a shower. The call center staff stated that skin exposure may cause a burning sensation and that symptoms typically develop soon after the exposure and resolve spontaneously within 24 hours. Call center staff said to remove the contaminated clothing and rinse off the exposed skin with running water for atleast 20 minutes. If symptoms develop, she can apply a light coating of Vitamin E oil every four hours as needed, it may help to reduce the intensity and duration of the sensation. Consult a health care professional if symptoms persist for more than 24 hours and to call back with any additional questions or concerns.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

Signs were expected to be mild and self-limiting.