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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-3441

2. Registrant Information.

Registrant Reference Number: PROSAR Case # 1-22601890

Registrant Name (Full Legal Name no abbreviations): The Hartz Mountain Corporation

Address: 400 Plaza Drive

City: Secaucus

Prov / State: NJ

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.

12-MAY-10

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

10-MAY-10

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.       PMRA Submission No.       EPA Registration No. 2596-86

Product Name: Hartz UltraGuard Flea Tick Dip for Dogs and Cats

  • Active Ingredient(s)
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration 1.11 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .67 %
    • PYRETHRINS
      • Guarantee/concentration .33 %

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: 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).

The caller did not specify application technique other than to state he had applied to his animal

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

Dog / Chien

3. Breed

Mixed breed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Gastrointestinal System
    • Symptom - Anorexia
  • Skin
    • Symptom - Discolouration
  • General
    • Symptom - Death

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?

Unknown

14. b) How long was the animal hospitalized?

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

1-22601890: The reporter, an animal owner, called on 05/12/10 to report exposure of his 6 year mixed breed dog to a pesticide containing the active ingredients Pyrethrins, Piperonyl butoxide, and N-octyl bicycloheptene dicarboximide. The caller reports he applied the product to his animal 05/09/10. He did not specify application technique. He reports he had used the same product on the animal last year with no ill effect. The caller reported skin and fur discoloration the morning after application and rinsed the product from the animal. He also reports he noted ataxia and poor appetite that morning. The caller reports he brought the animal to the veterinarian on 05/11/10 when the symptoms did not abate. The veterinarian was reported to have been given "vitamins and vitamin K1" on an outpatient basis. The owner brought the animal back to the veterinarian on 05/12/10 and the animal was reported to have been given IV fluids and died a short time later. He did not specify if the animal had been hospitalized or not. The caller was informed that the product is well tolerated when used according to label instructions and offered assistance with necropsy to determine the cause of the animal¿¿¿s death. 05/21/10 necropsy results were provided from University of (name) of Veterinary Medicine Veterinary Diagnostic Laboratory. The pathologist comments are as follows: "The most significant change is the significant lack of red blood cells (presumed anemia) observed in all the sections of tissue examined most likely from the severe parasite infestation described in the clinical history. The increased amounts of edema are most likely secondary to anemia, hypoproteinemia and hypovolemia. The significant centrilobular dropout and degeneration is secondary to severe hypoxia, most likely secondary to anemia (hypovolemia) and reduced myocardial efficiency. Most often hypovolemia, hypoproteinemia, and hypoxia result in an unexpected cardiac arrhythmia and sudden death. No significant inflammatory reactions or neoplastic processes are observed in the sections examined."


To be determined by Registrant

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

Death

19. Provide supplemental information here