Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-3952

2. Registrant Information.

Registrant Reference Number: Prosar 1-19354420

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.

30-JUL-09

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSOURI

6. Date incident was first observed.

26-JUL-09

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2596-22

Product Name: UltraGuard Rid Flea/Tick Shampoo for Dogs Clean Fresh Scent

• Active Ingredient(s)
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • Guarantee/concentration .149 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration .089 %
  • PYRETHRINS
    • Guarantee/concentration .045 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

No

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

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.

Medical Professional

2. Demographic information of data subject

Sex: Male

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

3. List all symptoms, using the selections below.

System

• Renal System
  • Symptom - Renal failure
  • Symptom - Anuria

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)

Poisoning from ingestion of the pesticide

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

10. Route(s) of exposure.

Oral

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>1 wk <=1 mo / > 1 sem < = 1 mois

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.)

1-19354420: The reporter, a physician, called on 7/30/09 to report the exposure of a(age) boy to a canine flea and tick spray containing the active ingredients Pyrethrins, Piperonyl Butoxide, and N-Octyl Bicycloheptene Dicarboxmide. According to the reporter, the patient is autistic and had a history of pica. He had ingested 45 ml or 1.5 ounces of the product approximately 2-3 weeks previously, and had presented in renal failure about 4 days prior to the call. The patient had no urine output on presentation and was on the verge of dialysis; however, by the time of the call the patient had responded to treatment and seemed to be doing better. Biopsy of the kidneys indicated that failure was possibly due to phosphorus/phosphates. The reporter was not concerned with the active ingredients in the product, but did request information regarding inactive ingredients. The physician was especially interested if any sodium phosphates were present such as would be found in soaps, cleansing agents, or detergents. A list of the inert ingredients was discussed with the reporter, including the absence of phosphates. No additional information is available regarding the status of the patient.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.