Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6350

2. Registrant Information.

Registrant Reference Number: 1-54217861

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.

05-OCT-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

27-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)

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PMRA Registration No. 23075      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Premise Plus Spray

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

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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 stated her landlord had a PCO come in and spray the product, it was sprayed all over their house, couches and beds on September 27th, 2018. Her room mate continued to spray the house every day since the initial spray. This was an off label use. If a pest problem persists, a second application two to three weeks after the initial treatment may be necessary.

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

• General
  • Symptom - Fever

• Respiratory System
  • Symptom - Irritated throat

• Gastrointestinal System
  • Symptom - Stomach cramps
  • Symptom - Diarrhea

• General
  • Symptom - Fatigue

• Respiratory System
  • Symptom - Difficulty Breathing

4. How long did the symptoms last?

Unknown / Inconnu

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

Non-occupational

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

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.

Skin

Respiratory

11. What was the length of exposure?

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

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

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 said that PCO had sprayed the product on September 27th, 2018. It was sprayed all over the house, couches, and beds and her room mate continued to spray the product in the house every day since the initial treatment. The caller developed symptoms while her room mate was asymptomatic. The call center staff stated that the described exposure would not be expected to cause the majority of symptoms described and recommended the caller seek medical attention to explore other possible causes of the symptoms, especially fever. The call center staff stated inhalation of this product may lead to irritation of the upper respiratory tract, and that adverse health effects are typically limited to the upper respiratory tract and resolve without affecting other body functions. The call center staff stated that the caller should be removed from the source of the fumes and placed in an area with fresh air and adequate ventilation, and to also ventilate the area by opening windows and doors and to consider adding portable fans until the odor has dissipated. Call center staff said she may also wash treated surfaces with an appropriate household cleaner. The call center staff said that patients who smoke or have underlying respiratory conditions may experience more pronounced symptoms that require medical attention. Finally, the call center staff recommended seeking medical attention if the patient's symptoms do not resolve within 30 minutes of the call, if the patient develops shortness of breath, or if breathing is difficult to call 911, and to call back with any additional questions or concerns.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

This was off-label use, after treatment if needed another treatment would be recommended at least 2-3 weeks after initial spray. This product is only labeled for using on pet bedding, not human bedding.