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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-5251

2. Registrant Information.

Registrant Reference Number: Prosar 1-20309803

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-OCT-09

5. Location of incident.

Country: UNITED STATES

Prov / State: KENTUCKY

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 a 50 pound dog 1 month prior to the report, and to a 40 pound dog on 09/29/2009. NOTE: The product is labeled for use on dogs weighing between 4-15 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

Mixed Breed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.67

7. Weight (provide a range if necessary )

50

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking
  • General
    • Symptom - Lethargy
    • 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

1-20309803: A reporter (dog owner) called on 10/05/2009 to report the exposure of 2 dogs to a flea and tick product containing the active ingredient Phenothrin. According to the reporter, the product was applied to Dog #1 (1st Subform III) one month prior to the report. Within 24-48 hours following product application, the dog stopped eating and developed lethargy and difficulty walking. The dog was not evaluated by a veterinarian and died a few days after the signs developed. The product was applied to newly purchased Dog #2 (2nd Subform III) on 09/29/2009. On 09/30/2009, Dog # 2 was anorexic, lethargic, and having difficulty walking. Dog #2 died on 10/02/2009. The dog was not evaluated by a veterinarian. The reporter stated that he has used the product numerous times on other pets without adverse effects. The reporter was advised that the signs described are not expected with routine use of the product. No further information was obtained. NOTE: This product is labeled for use on dogs weighing 4-15 pounds.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Mixed Breed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.5

7. Weight (provide a range if necessary )

40

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

  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking
  • General
    • Symptom - Lethargy
    • 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

1-20309803: A reporter (dog owner) called on 10/05/2009 to report the exposure of 2 dogs to a flea and tick product containing the active ingredient Phenothrin. According to the reporter, the product was applied to Dog #1 (1st Subform III) one month prior to the report. Within 24-48 hours following product application, the dog stopped eating and developed lethargy and difficulty walking. The dog was not evaluated by a veterinarian and died a few days after the signs developed. The product was applied to newly purchased Dog #2 (2nd Subform III) on 09/29/2009. On 09/30/2009, Dog # 2 was anorexic, lethargic, and having difficulty walking. Dog #2 died on 10/02/2009. The dog was not evaluated by a veterinarian. The reporter stated that he has used the product numerous times on other pets without adverse effects. The reporter was advised that the signs described are not expected with routine use of the product. No further information was obtained. NOTE: This product is labeled for use on dogs weighing 4-15 pounds.


To be determined by Registrant

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

Death

19. Provide supplemental information here