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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-3765

2. Registrant Information.

Registrant Reference Number: PROSAR Case #: 1-22956839

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

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.

09-JUN-10

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

09-JUN-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. 2596-151

Product Name: UltraGuard Flea Tick Drops for Dogs Puppies

  • Active Ingredient(s)
    • D-PHENOTHRIN

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: Animal / Usage sur un animal domestique

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

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: >1 <=6 yrs / > 1 < = 6 ans

3. List all symptoms, using the selections below.

System

  • Gastrointestinal System
    • Symptom - Diarrhea

4. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

6. a) Was the person hospitalized?

Unknown

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Contact with treated area

What was the activity? A child petting and laying with an animal to which the product was applied

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?

Unknown / Inconnu

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.)

1-22956839- The reporter, a parent, called to indicate exposure of her child to an insecticide containing the active ingredient Phenothrin. The caller indicated she had applied the product, a topical flea and tick drop, to her dog 5 days before the initial contact with the registrant. The animal was kept away from her (age) year female child for an unspecified time frame but she did indicate it was until the product had dried on the dog. The child was then allowed to both pet and lay with the animal. The caller noted the day of the initial contact with the registrant (5 days after application) the child had developed diarrhea. She asks if the symptom could be due to the described exposure. The caller was told mild dermal irritation can be seen in some individuals following dermal contact with wet product, but diarrhea would be unexpected following dermal contact with dried product. The time line was also noted to be make symptoms unlikely to be related to exposure. No further information is known.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.