Health Canada
Symbol of the Government of Canada
Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-3868

2. Registrant Information.

Registrant Reference Number: 1-53138745

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.

12-JUL-18

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

12-JUL-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. 23075      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Premise Plus 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: Unknown / Inconnu

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

Caller reported that her co-worker inappropriately sprayed this product on herself 45 minutes after handling an animal with fleas.

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.

Other

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 - Rash

4. How long did the symptoms last?

Unknown / Inconnu

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

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

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

>30 min <=2 hrs / >30 min <=2 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.)

Caller reported her co-worker in a pet shop inappropriately applied the product directly on her skin after handling an animal with fleas. Within 30 minutes of the application, the co-worker, who has a history of sensitive skin, broke out in a rash. She went home to take a shower and remove the product. The call center specialist stated that toxicity is not anticipated in this type of scenario and that the patient may or may not have an unrecognized sensitivity to one of the active or associated ingredients in a given product. The patient was told to consider a labeled dose of an OTC antihistamine such as diphenhydramine and if any dermal symptoms worsen in intensity, or any other symptoms develop, to seek medical attention.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

This was an off-label use of this product, as it should never be applied directly on the skin. Caller reported that her co-worker is doing well and the symptoms had resolved.