Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7258

2. Registrant Information.

Registrant Reference Number: ProPharma Group case:# 1-45982122

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.

Domestic Animal

4. Date registrant was first informed of the incident.

19-OCT-16

5. Location of incident.

Country: UNITED STATES

Prov / State: VIRGINIA

6. Date incident was first observed.

14-OCT-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. 2596-78

Product Name: HARTZ ULTRA GUARD FLEA &TICK POWDER FOR CATS

• Active Ingredient(s)
  • TETRACHLORVINPHOS
    • Guarantee/concentration 3.3 %

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7. b) Type of formulation.

Dust

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 III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

6.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death
  • Symptom - Lethargy

• Cardiovascular System
  • Symptom - Other
  • Specify - weak pulses

• Nervous and Muscular Systems
  • Symptom - Ataxia

• Respiratory System
  • Symptom - Difficulty Breathing

• General
  • Symptom - Hypothermia

• Renal System
  • Symptom - Lack of control of urination

• Blood
  • Symptom - Anemia

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

1-45982122 - The reporter, a pet owner, indicated her cat was exposed to an insecticidal powder containing the active ingredient tetrachlorvinphos. Five days before the day of initial contact with the registrant, the reporter applied the product to her 6.5-pound, 6-year-old, female domestic longhair cat. That evening the cat seemed a little lethargic. Four days before the day of initial contact, the reporter noticed the cat had urinated on herself, so the reporter gave the cat a bath. Later that day, the reporter brought the cat to an emergency veterinary facility where an exam revealed weak pulses, difficulty breathing, hypothermia, severe anemia, and ataxia. The cat was hospitalized on fluid therapy, oxygen, and medications, but died three days before the day of initial contact with the registrant. The reporter was offered condolences and advised that this is not an expected reaction to the product. The cat may have had underlying complications from the flea infestation and anemia. A necropsy was discussed but the reporter declined. No follow-up was attempted. No additional information is available.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here