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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-5365

2. Registrant Information.

Registrant Reference Number: 10-01-24097415

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.

14-SEP-10

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

13-SEP-10

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. 2724-777-2596

Product Name: Hartz Ultraguard Plus Flea and Tick Carpet Powder

  • Active Ingredient(s)
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .5 %
    • PYRETHRINS
      • Guarantee/concentration .075 %
    • PYRIPROXYFEN
      • Guarantee/concentration .02 %

7. b) Type of formulation.

Dust

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).

Product was inappropriately applied to carpet inside of patient's home on September 13th., 2010.

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.

Medical Professional

2. Demographic information of data subject

Sex: Female

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

3. List all symptoms, using the selections below.

System

  • Respiratory System
    • Symptom - Respiratory distress
    • Symptom - Shortness of breath
    • Symptom - Acute respiratory distress syndrome

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?

Yes

6. b) For how long?

Unknown

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)

None

10. Route(s) of exposure.

Respiratory

11. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 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.)

Product was applied by a [age] year old female to the carpet inside of her home and while applying the patient inhaled some of the powder. A fan was running when the product was applied. The patient was brought to the hospital and was put on a ventilator and given antibiotics and is suffering from Acute Respiratory Distress Syndrome. The patient had a pre- existing condition, asthma, and was also a smoker. The Prosar Specialist said that it was not recommended that a person with a pre-existing respiratory condition use the product.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

On September 27th, the Prosar specialist spoke with [name], the ICU supervisor, and told that the patient had a tracheostomy and was off the ventilator. [name] also said that the patient will likely be discharged to a rehab service next week. This product was not used according to label directions: Do not apply this product in a way that will contact adults, children or pets either directly or through drift.