Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-3846
2. Registrant Information.
Registrant Reference Number: 1-25924789
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.
20-APR-11
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
18-APR-11
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. 25739
PMRA Submission No.
EPA Registration No. PCP 25739
Product Name: Vet-Kem Siphotrol 1000 Double Action Premise Treatment
- 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 or around April 13th, 2011. The caller sprayed her home with product and also used off label on her mattress.
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: Unknown / Inconnu
3. List all symptoms, using the selections below.
System
4. How long did the symptoms last?
>24 hrs <=3 days / >24 h <=3 jours
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
Non-occupational
8. How did exposure occur? (Select all that apply)
Contact with treated area
Amount of time between application and contact 6
Hour(s) / Heure(s)
What was the activity? sleeping on previously sprayed mattress
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?
>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.)
On or around April 18th the caller became symptomatic. Product was inappropriately applied to her mattress and was allowed to dry for 6 hours several days ago. Caller was not seen by an HCP, was instructed to remove contaminated clothing and rinse exposed skin for at least 20 minutes. Then if skin irritation develops, vitamin E/aloe vera containing products. Do not apply any creams or lotions to open sores, blisters or peeled skin. If symptoms persist or worsen over the next 24 hours seek medical attention.
To be determined by Registrant
14. Severity classification.
Minor
15. Provide supplemental information here.
Follow up call was placed on April 27th, 201, message left on voice mail. The product was not used according to label directions. ie. avoid contact with skin eyes and clothing. Harmful if swallowed, inhaled or absorbed through the skin. Label does not include application to bedding.