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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4967

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16340318

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.

30-JUN-08

5. Location of incident.

Country: UNITED STATES

Prov / State: OKLAHOMA

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2596-147

Product Name: UltraGuard One Spot Flea Egg and Larvae Treatment for Cats and Kittens

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 2.9 %

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 reporter applied the product to her geriatric pet on 6/16/08. The product is not designed to be used on aged animals.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

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

Female

6. Age (provide a range if necessary )

15

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Hiding
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Muscle weakness
    • Symptom - Seizure
  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

No

14. a) Was the animal hospitalized?

No

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

1-16340318: The reporter called on 6/30/08 to report the death of her cat after the application of a topical flea and tick product containing the active ingredient Methoprene. According to the reporter, she had applied the product to her 15 year old cat on 6/16/08. On 6/25/08, the reporter noticed the cat had become lethargic, anorexic, and had begun to hide. By 6/26, the cat had begun experiencing muscle weakness and ataxia, had vomited, and had ┐┐┐some type of seizure┐┐┐. Per the reporter, the cat had passed away the morning of 6/26. The reporter inquired about the safety profile of the product; however, since the cat had been an indoor/outdoor cat, the reporter also speculated the cat may have gotten into something. The safety profile of the product was discussed, including the fact that symptoms of an adverse reaction would typically occur within 24 hrs after product application. The company sponsored necropsy program was discussed but the reporter no longer had access to the remains. Note: the product is not designed to be used on aged animals.


To be determined by Registrant

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

Death

19. Provide supplemental information here