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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4144

2. Registrant Information.

Registrant Reference Number: PROSAR Case 1-16495690

Registrant Name (Full Legal Name no abbreviations): The Hartz Mountain Company

Address: 400 Plaza Drive

City: Secaucus

Prov / State: New Jersey

Country: USA

Postal Code: 07094-3688

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

07-AUG-08

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

07-AUG-08

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. 25654      PMRA Submission No.       EPA Registration No.

Product Name: Control Pet Care System Flea and Tick Guard for Dogs

  • Active Ingredient(s)
    • TETRACHLORVINPHOS

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).

Reporter was spraying product on 8/7/2008 and product drifted back into her right eye. It is presumed that the reporter was spraying the product on a pet.

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: Female

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

3. List all symptoms, using the selections below.

System

  • Eye
    • Symptom - Burning eye

4. How long did the symptoms last?

>30 min <=2 hrs / >30 min <=2 h

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)

Drift from the application site

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.

Eye

11. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 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.)

1-16495690: The reporter called on 8/7/2008, to report her own exposure to a Flea and Tick product containing the active ingredient Tetrachlorvinphos. According to the reporter, about 5 minutes prior to the call she was spraying the product and it drifted back into her right eye. The reporter was wearing contact lenses at the time of exposure and by the time of the call had not yet removed them. The report flushed her eye with water immediately after exposure to the product, and experienced a burning sensation in her eye. The safety profile of the product was discussed in that the product can irritate the eyes, but is not corrosive or expected to cause corneal burns. A recommendation was made to remove the contacts and discard them if they are disposal. If not, a recommendation was made to irrigate the contacts and let the eyes return to their normal lubrication before wearing the contacts again. Additionally, it was recommended that the eyes be rinsed with tepid tap water or normal saline for at least 20 minutes. The reporter was told not to use over the counter eye drops and to seek medical attention if the symptoms worsened or persisted more than 6 hours. A follow-up call on 8/8/2008 revealed the reporter┐s eye was better. She had flushed the eye and disposed of the contacts she was wearing at the time of exposure. Her symptoms started to improve within 30 minutes of treatment.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.