Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4172

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16328355

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.

26-JUN-08

5. Location of incident.

Country: UNITED STATES

Prov / State: VIRGINIA

6. Date incident was first observed.

25-JUN-08

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. 2596-149

Product Name: UltraGuard Plus Foaming Shampoo for Cats and Kittens

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .101 %
  • D-TRANS ALLETHRIN
    • Guarantee/concentration .109 %
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • Guarantee/concentration .154 %

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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 product was applied to the reporter's 3 cats on 6/25/08.

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 Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

7.47

lbs

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

<=30 min / <=30 min

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Seizure

• Blood
  • Symptom - Anemia
  • Symptom - Leukocytosis

• 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

1-16328355: The reporter, a veterinarian, called on 6/26/08 to report the death of a 3 year male cat following application of a topical flea and tick shampoo containing the active ingredients Allethrin and Methoprene. According to the reporter, the cat had been bathed with the product on 6/25/08. Within 30 seconds of application, the cat had developed seizures. It had been seen at an emergency clinic on 6/25. The blood work done at the clinic showed the cat had developed severe anemia (HCT 11%) and had a high white cell count of 81,000 (range 5,500 ¿ 19,500). The clinic had given the cat a transfusion of oxyglobin. It had then presented to the reporter on 6/26 and had passed away after presentation. The reporter stated that two other cats in the family had also been bathed on 6/25 and had remained asymptomatic. The reporter inquired about and was given information relating to the safety profile of the product. It was discussed that the cat could have had an individual sensitivity to the product. The company sponsored necropsy program was discussed, and the appropriate forms were faxed to the reporter. Necropsy results indicated: 1) Severe anemia, 2) Multifocal liver degeneration and necrosis, 3) Multifocal kidney degeneration, 3) Multifocal myocardial (heart) degeneration, 4) Multifocal pulmonary edema, 5) Multifocal thrombi and emboli, 6) Multifocal, suppurative dermatitis with hyperkeratosis and marked ectoparasitism (fleas). Comments by the attending pathologist indicated that the degeneration and necrosis seen in the liver, kidney, and heart would be consistent with hypoxia of greater than 24 hours and would most likely reflect the cat¿s severely anemic state. The pulmonary edema and multifocal thrombi and emboli would likely be secondary to decreased cardiac performance brought on by hypoxia. Skin changes would be consistent with antigentic stimulation from flea parasitism. The bone marrow had a myeloid:erythroid ratio of 4:1, which would reflect the increased number of circulating leukocytes (white blood cells). Since there was no evidence of inflammation in the internal organs, the increased leukocyte numbers would be consistent with the chronic inflammation seen in the skin. Sections of the brain did not contain any evidence of degeneration, necrosis, inflammation, or neoplasia. According to the pathologist, the seizure activity most likely would have been secondary to hypoxia, decreased cardiac performance, pulmonary edema, and increased hepatocellular (liver) degeneration. An Aerobic culture indicated rare growth of Coagulase negative Staphylococcus species in lung tissue, 1 colony of Coliforms in lung tissue, 1 colony of Streptococcus canis in lung tissue, and light growth of Streptococcus canis in liver tissue.

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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