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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-1954

2. Registrant Information.

Registrant Reference Number: Prosar 1-17989191

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.

02-APR-09

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

02-APR-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. 25922      PMRA Submission No.       EPA Registration No.

Product Name: Control Pet Care System Once A Month Flea/Tick Treatment for Dogs

  • Active Ingredient(s)
    • PERMETHRIN

7. b) Type of formulation.

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 5 pound dog on 04/02/2009. NOTE: This product is not labeled for use on dogs weighing less than 14kg (30 pounds).

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

Dog / Chien

3. Breed

Maltese

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.33

7. Weight (provide a range if necessary )

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 - Vocalizing
    • Symptom - Pain
    • Specify - Back legs seem painful
    • Symptom - Biting
    • Specify - Biting at back legs
  • Skin
    • Symptom - Erythema

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

14. a) Was the animal hospitalized?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Unknown/Inconnu

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

1-17989191: A reporter called on 04/02/2009 to report the exposure of her puppy to a flea and tick product containing the active ingredient Permethrin. According to the reporter, the product was applied to the dog on 04/02/2009. At an unknown time following product application, the dog was vocalizing while standing and seemed painful in his hind limbs. The reporter also stated that the dog was biting at his hind limbs and that his rectum appeared red. The reporter had bathed the dog with a puppy shampoo a few hours prior to the report. The reporter was advised that the product is not intended to be used on dogs weighing less than 14kg. A recommendation was made to bathe the puppy with a hand dish soap to remove the product. The reporter was advised that an overdose of the product may result in neurologic signs such as tremors and seizures. The reporter was also advised that the reported sign of pain in the hind limbs would not be expected with product exposure. The reporter was told that dermal irritation may cause signs of discomfort. A recommendation was made to consult a veterinarian if the dog's signs persisted or worsened. Attempts at follow up were unsuccessful. No further information was obtained.


To be determined by Registrant

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

Minor

19. Provide supplemental information here