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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-4009

2. Registrant Information.

Registrant Reference Number: Prosar 1-19693587

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.

31-AUG-09

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

28-AUG-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. 2596-22

Product Name: UltraGuard Rid Flea Dog Shampoo Refreshing Fresh Citrus 18 fl oz

  • Active Ingredient(s)
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration .149 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .089 %
    • PYRETHRINS
      • Guarantee/concentration .045 %

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 4 dogs on 08/25/2009.

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

Other

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 )

4

7. Weight (provide a range if necessary )

Unknown

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

  • Gastrointestinal System
    • Symptom - Anorexia
  • 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.

Yes

14. a) Was the animal hospitalized?

Unknown

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

1-19693587: A reporter called on 08/31/2009 to report the exposure of 4 dogs to a flea and tick shampoo containing the active ingredients Pyrethrins, Piperonyl Butoxide, and NOBD. According to the reporter, the shampoo was applied to her 3 dogs and her family member's dog on 08/25/2009. On an unknown date, the family member's dog, Dog #1, (1st Subform III) developed anorexia and lethargy. Dog #1 was taken to a veterinarian where it died. The reporter was made aware of this on 08/28/2009. After being notified of Dog #1's death, she looked at her 3 dogs and noted that Dog #2 (2nd Subform III) had a rash on her abdomen. The other 2 dogs were asymptomatic. The reporter was advised that the product has a low level of toxicity and a wide range of safety when used as directed. If a dog has a sensitivity to an ingredient in the product, dermal redness, itching, or rash may develop. If an animal is suspected of having a sensitivity to the product, its use should be avoided in the future. Ingestion of the product may result in minor, transient gastrointestinal upset such as nausea, vomiting, and diarrhea. A recommendation was made to bathe Dog #2 in a hand dish soap and use a hydrocortisone product on the irritated areas. The reporter was also advised to have Dog #2 evaluated by a veterinarian if the signs persisted or worsened. A recommendation was made to have Dog #1's owner consider necropsy to determine cause of death. An attempt at follow up was unsuccessful. 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

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Sheltie

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

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

  • Skin
    • Symptom - Rash

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

1-19693587: A reporter called on 08/31/2009 to report the exposure of 4 dogs to a flea and tick shampoo containing the active ingredients Pyrethrins, Piperonyl Butoxide, and NOBD. According to the reporter, the shampoo was applied to her 3 dogs and her family member's dog on 08/25/2009. On an unknown date, the family member's dog, Dog #1, (1st Subform III) developed anorexia and lethargy. Dog #1 was taken to a veterinarian where it died. The reporter was made aware of this on 08/28/2009. After being notified of Dog #1's death, she looked at her 3 dogs and noted that Dog #2 (2nd Subform III) had a rash on her abdomen. The other 2 dogs were asymptomatic. The reporter was advised that the product has a low level of toxicity and a wide range of safety when used as directed. If a dog has a sensitivity to an ingredient in the product, dermal redness, itching, or rash may develop. If an animal is suspected of having a sensitivity to the product, its use should be avoided in the future. Ingestion of the product may result in minor, transient gastrointestinal upset such as nausea, vomiting, and diarrhea. A recommendation was made to bathe Dog #2 in a hand dish soap and use a hydrocortisone product on the irritated areas. The reporter was also advised to have Dog #2 evaluated by a veterinarian if the signs persisted or worsened. A recommendation was made to have Dog #1's owner consider necropsy to determine cause of death. An attempt at follow up was 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