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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-1825

2. Registrant Information.

Registrant Reference Number: 1-31778539

Registrant Name (Full Legal Name no abbreviations): WELLMARK INTERNATIONAL

Address: 100 STONE ROAD WEST, SUITE 111

City: GUELPH

Prov / State: ON

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-OCT-12

5. Location of incident.

Country: CANADA

Prov / State: NEWFOUNDLAND

6. Date incident was first observed.

07-OCT-12

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.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: not specific

  • 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 applied product inside his home on October 6, 2012.

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: Male

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

3. List all symptoms, using the selections below.

System

  • General
    • Symptom - Swelling
    • Symptom - Taste altered
    • Specify - unpleasant taste
  • Skin
    • Symptom - Red skin
    • Symptom - Blister
    • Specify - Bullae blisters
    • Symptom - Irritated skin
  • General
    • Symptom - Other
    • Specify - allergic reaction

4. How long did the symptoms last?

Unknown / Inconnu

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

Yes

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)

Coveralls (non-chemical resistant)

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>8 hrs <=24 hrs / > 8 h < = 24 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 wore a painters suit to apply product to his home on October 6, 2012. After applying product he hung the painters suit to dry inside out. Later in the day he put on the same painters suit inside out and mowed the lawn. The following day he experienced swelling on his face and lip. He went to the emergency department and was told he was having an allergic reaction. He was prescribed Prednisone and Benadryl and had recovered. He stopped this medication on October 11th, 2012 and has had swelling recur on his wrist on October 12, 2012. He started medication again on October 12th. Caller called again on October 15th as he had more symptoms, went to hospital on October 12th, 2012 at which time he said they gave him an i.v. with an unknown medication. Symptoms improved on October 14, 2012. He has not been back to see doctor since the 12th and continues to take Benedryl as prescribed.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

Follow up call was made on October 17th, he sometimes gets an outbreak of tender spots with tiny blisters on his legs. Symptoms come and go but he feels well. He will be seeing his doctor again to discuss the possibility of shingles.