Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7639

2. Registrant Information.

Registrant Reference Number: ProPharma Group case:# 1-46379946

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.

28-NOV-16

5. Location of incident.

Country: UNITED STATES

Prov / State: ILLINOIS

6. Date incident was first observed.

26-NOV-16

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. 2596-162

Product Name: HARTZ ULTRAGUARD PLUS FLEA AND TICK SHAMPOO FOR DOGS SOOTHING ALOE

• Active Ingredient(s)
  • D-PHENOTHRIN
    • Guarantee/concentration .27 %
  • PYRIPROXYFEN
    • Guarantee/concentration .025 %

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7. b) Type of formulation.

Liquid

Other (specify)

Shampoo

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: Unknown

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Reproductive System
  • Symptom - Miscarriage
  • Specify - 9.5 weeks

4. How long did the symptoms last?

Anticip. permanent/Permanence anticipée

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)

Other

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.)

1-46379946 - The reporter indicated her unborn child may have been exposed to a pesticidal shampoo containing the active ingredients D-phenothrin and pyriproxyfen. Two days before the day of initial contact with the registrant, the reporter who was nine-and-one-half weeks pregnant, was bathing her dog with the product. The reporter stated she did not wear gloves while bathing the dog. Later that night, the reporter indicated she miscarried her unborn child. The reporter was offered condolences for her loss. No follow-up was attempted. No additional information is available.

To be determined by Registrant

14. Severity classification.

Death

15. Provide supplemental information here.