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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2007-7764

2. Registrant Information.

Registrant Reference Number: PROSAR Case 1-15248814

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.

24-AUG-07

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

07-AUG-07

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. 26496      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Spot On Flea + Tick Control for Cat + Kittens

  • Active Ingredient(s)
    • (S)-METHOPRENE

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.

Other

2. Demographic information of data subject

Sex: Female

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

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Rash
    • Symptom - Itchy skin
    • Symptom - Blister
    • Specify - Fluid filled bumps

4. How long did the symptoms last?

>1 mo and <= 2mos / >1 mois et < = 2mois

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)

Contact with treated area

What was the activity? Contact with Treated Cat

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.

Unknown / Inconnu

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.)

History: Caller reports that she applied product to her cat, and that her daughter pet the cat after this application, and developed a itching, red rash, with fluid-filled bumps afterwards. Caller states that her daughter has been evaluated by a physician, and has tried oral Benadryl, topical hydrocortisone/calamine lotion, and cold compresses without incomplete relief. Caller reports that the rash has been present for 3 weeks, and is now spreading and getting worse. Rash is present on stomach, upper legs, arms, and neck. Assessment: This is not an expected effect of routine product use. Patient may or may not have an unrecognized sensitivity to one of the active or associated ingredients in a given product. There are several possible causes of a rash including sensitivity to a household or commercial product, food product, naturally occurring environmental agent, or medication. Rashes may also form as a result of illness or exposure to heat. Recommend consulting a physician to help determine the cause of the rash. Suggest consultation with dermatologist, given severity and duration of symptoms, and lack of relief with current medications. 08/31/07 Follow-Up Caller said that patient is doing much better. She states that she had symptoms for about 1-1.5 months. She saw her MD and was given a special cream. She states that she is still itchy from time to time. Where rash was the skin is rougher than it used to be. Rec'd to apply Vit E oil to that area.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.