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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-1583

2. Registrant Information.

Registrant Reference Number: Prosar case 1-15946228

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.

12-MAR-08

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

24-FEB-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. 2596-151

Product Name: Advanced Care 3 in 1 Once a Month Flea and Tick Drops for Dogs

  • 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).

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

Dog / Chien

3. Breed

Chihuahua/Terrier Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

13

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
  • Gastrointestinal System
    • Symptom - Anorexia
    • Symptom - Bloody vomit
  • General
    • Symptom - Hypothermia
  • Renal System
    • Symptom - Renal failure
  • Blood
    • Symptom - Blood urea nitrogen increased
    • Specify - Increased BUN
    • Symptom - Blood urea nitrogen increased
    • Specify - Increased Creatinine
    • Symptom - Hypokalemia
  • General
    • Symptom - Death
  • Blood
    • Symptom - Thrombocytopenia

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?

3

Day(s) / Jour(s)

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

1-15946228: The reporter alerted the registrant by mail that her 3 year old dog had been exposed to a product containing Phenothrin on 2/23/08 and within 24 hrs. had become lethargic and anorexic, with episodes of hematemesis. The reporter stated she took the dog to a veterinarian for evaluation on 2/25/08. Blood tests were run including a Parvovirus test, and the dog was diagnosed with renal failure. Elevations in BUN and Creatinine, a depressed Potassium level, and Thrombocytopenia were among the most significant laboratory findings. Treatment was given including IV Fluids, IV antibiotics, Potassium supplementation, anti-emetics, and vitamin B12. The dog passed away in hospital on 2/28/08.


To be determined by Registrant

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

Death

19. Provide supplemental information here