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Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-1837

2. Registrant Information.

Registrant Reference Number: PROSAR Case #1-25359666

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.

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

Unknown

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.

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

Product Name: UltraGuard Rid Flea Tick Shampoo for Dogs

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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

Site: Other / Autre

Préciser le type: The caller applied the product to her own hair

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?

No

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

• Respiratory System
  • Symptom - Shortness of breath

• Cardiovascular System
  • Symptom - Other
  • Specify - "leaky valve"
  • Symptom - Arrhythmia

• Respiratory System
  • Symptom - Other
  • Specify - sinus infection

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)

Application

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.)

1-25359666- The reporter calls to indicates exposure to an insecticidal product containing the active ingredients pyrethrins, piperonyl butoxide, and N-octyl bicycloheptene dicarboximide. The caller indicates she had used the product, a flea and tick shampoo labeled for use on dogs, on her own hair ¿¿¿on and off¿¿¿ for the past nine years after she had obtained fleas from her dog. The caller indicated in 2004 she was diagnosed by her MD with ¿¿¿an irregular heartbeat and leaky valves¿¿¿. She indicates she also experienced shortness of breathe at that point. The reporter indicates her shortness of breath has gotten worse lately and wonders if the use of this product could be related to her health problems. The caller was advised the product is not labeled for use on humans and further use, as such, was discouraged. The caller was advised the ectoparasite Ctenocephalides felis does not prefer humans as a host. She was, lastly, advised the symptoms described would not be expected following any type of exposure to these active ingredients. They are inconsistent with the toxicity profile of the product. She was advised to follow up with her heath care provider to address her symptoms. No further information is available.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.