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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-2684

2. Registrant Information.

Registrant Reference Number: Prosar 1-18343332

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.

05-MAY-09

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

Unknown

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. 2596-151

Product Name: UltraGuard Flea/Tick Drops for Dogs/Puppies 4-15 lbs

  • Active Ingredient(s)
    • D-PHENOTHRIN
      • Guarantee/concentration 85.7 %

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 dog on an unknown date. An unknown home spray was also used around the time of product application.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Papillion

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

7.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Skin
    • Symptom - Pale mucous membrane colour
    • Specify - "Gray mucous membranes"
  • Blood
    • Symptom - Anemia
  • Nervous and Muscular Systems
    • Symptom - Paralysis
  • Renal System
    • Symptom - Lack of control of urination
  • Liver
    • Symptom - Hepatic failure
  • 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?

Yes

14. b) How long was the animal hospitalized?

Unknown

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

1-18343332: A reporter (veterinarian) called on 05/05/2009 to report the exposure of a dog to a flea and tick product containing the active ingredient Phenothrin. According to the reporter, the product was applied to the dog on an unknown date. By the following day, the dog was lethargic, had gray mucous membranes, was anemic, had acute paralysis, and was urinating on itself. The reporter performed blood work and diagnosed the dog with liver failure. The dog was treated with IV fluids and steroids. The dog died within 36 hours of product exposure. The reporter noted that an unknown home spray was also used around the time of product application. The reporter was advised that the signs described are not expected with routine use of the product. The reporter was also advised that a necropsy would be helpful in determining the cause of the dog's signs. No further information was obtained.


To be determined by Registrant

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

Death

19. Provide supplemental information here