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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-3979

2. Registrant Information.

Registrant Reference Number: Prosar 1-19427820

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.

06-AUG-09

5. Location of incident.

Country: UNITED STATES

Prov / State: NEBRASKA

6. Date incident was first observed.

17-JUL-09

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/Larvae Treatment for Cats/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 product was applied to 2 cats (a 7 year old cat and a 15 year old cat) on 07/03/2009 and on 08/03/2009. NOTE: This product is not labeled for use on aged cats (defined as older than 10 years of age).

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

Male

6. Age (provide a range if necessary )

15

7. Weight (provide a range if necessary )

11.6

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 - Lethargy
    • Symptom - Vocalizing
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Listless
  • Renal System
    • Symptom - Urinary incontinence
  • 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

1-19427820: A reporter (cat owner) called on 08/06/2009 to report the exposure of her 2 cats to a flea egg and larvae product containing the active ingredient Methoprene. According to the reporter, the product was applied to both cats on 07/03/2009. Two weeks after product application, the cats became lethargic. About 3 weeks after product application, Cat #1 (1st Subform III) started howling. The reporter applied another dose of product to both cats on 08/03/2009. Cat #1 became more lethargic, anorexic, listless, and incontinent of urine. Cat #1 died on 08/06/2009. Cat #2 (2nd Subform III) became more lethargic and anorexic following product application on 08/03/2009. The reporter also found fleas on Cat #2 and took him to the veterinarian prior to the report. Cat #2 was found to be anemic and dehydrated. Cat #2 was receiving IV fluids and another non-company flea treatment. The reporter was advised that the active ingredient has little to no mammalian toxicity and would not be expected to result in adverse events. If adverse events are suspected to be from product application, it is recommended to bathe the animal in a non-insecticidal shampoo. A recommendation was made to consider necropsy to determine cause of death. On follow up, the reporter stated that Cat #2 had been bathed and another non-company flea product had been applied. No further information was obtained. NOTE: This product is not labeled for use in aged cats (defined as older than 10 years of age). It is also not labeled for control of adult fleas. It is intended to kill and prevent development of flea eggs and larvae.


To be determined by Registrant

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

Death

19. Provide supplemental information here