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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6356

2. Registrant Information.

Registrant Reference Number: PROSAR case #: 1-35370613

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.

29-OCT-13

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

26-OCT-13

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. 2596-167

Product Name: Ultraguard Flea/Tick Prevention for Dogs/Puppies 15-30 lbs.

  • Active Ingredient(s)
    • ETOFENPROX
      • Guarantee/concentration 55 %
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration 1 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 10 %

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

Mixed breed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

15

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
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Difficulty getting up
    • Symptom - Seizure
  • General
    • Symptom - Dehydration
    • 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

1-35370613 -The reporter, a pet owner, indicated that his dog was exposed to a spot-on product containing the active ingredients etofenprox, n-octyl bicycloheptene dicarboximide and piperonyl butoxide. The reporter applied the product to their 2-year-old, 15 pound, male mixed breed dog (Subform III #1) and to his 2-year-old, 23 pound, male mixed breed dog (Subform III #2) three days prior to initial contact with the registrant. About 8-10 hours later both dogs were vomiting. The following day the dogs seemed dehydrated, would not eat and were having a hard time standing. The dogs were brought the emergency veterinary clinic but they were not evaluated or treated due to financial constraints. That evening both dogs began to have seizures and then in the early morning, two days after the product had been applied both dogs died. A necropsy was recommended to help determine a cause for death but at the time of the initial call both dogs had already been buried. No further information is available.


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 )

2

7. Weight (provide a range if necessary )

23

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
    • Symptom - Vomiting
  • General
    • Symptom - Dehydration
  • Nervous and Muscular Systems
    • Symptom - Difficulty getting up
    • Symptom - Seizure
  • General
    • 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

1-35370613 -The reporter, a pet owner, indicated that his dog was exposed to a spot-on product containing the active ingredients etofenprox, n-octyl bicycloheptene dicarboximide and piperonyl butoxide. The reporter applied the product to their 2-year-old, 15 pound, male mixed breed dog (Subform III #1) and to his 2-year-old, 23 pound, male mixed breed dog (Subform III #2) three days prior to initial contact with the registrant. About 8-10 hours later both dogs were vomiting. The following day the dogs seemed dehydrated, would not eat and were having a hard time standing. The dogs were brought the emergency veterinary clinic but they were not evaluated or treated due to financial constraints. That evening both dogs began to have seizures and then in the early morning, two days after the product had been applied both dogs died. A necropsy was recommended to help determine a cause for death but at the time of the initial call both dogs had already been buried. No further information is available.


To be determined by Registrant

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

Death

19. Provide supplemental information here