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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0431

2. Registrant Information.

Registrant Reference Number: ProPharma case: 1-42747784

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.

17-DEC-15

5. Location of incident.

Country: UNITED STATES

Prov / State: OREGON

6. Date incident was first observed.

12-DEC-15

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 5-14 pounds

  • 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).

The pet owner applied the product to her 7 to 8 week old, 2.6 pound mixed breed dog five days prior to initial contact with the registrant. Per package labeling the product is not meant for dogs less then 5 pounds and under 12 weeks of age.

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Mixed breed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.166

7. Weight (provide a range if necessary )

2.6

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

  • General
    • Symptom - Hypothermia
  • Nervous and Muscular Systems
    • Symptom - Fasciculations
    • Symptom - Recumbent
    • Symptom - Unresponsive
    • Specify - non-responsive
  • 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?

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

1-42747784 - The reporter, a veterinarian, indicated that a dog was exposed to a spot-on insecticide containing the active ingredients etofenprox, n-octyl bicycloheptene dicarboximide and piperonyl butoxide. The pet owner applied the product to her 7 to 8-week-old, 2.6 pound, female mixed breed dog five days prior to initial contact with the registrant. The puppy did not have any symptoms until the morning of initial contact. At the time of the call, the reporter indicated that the dog had a temperature of 98.6F, had facial twitching, was laterally recumbent and non-responsive. Per package labeling the product is not meant for dogs less than 5 pounds and under 12 weeks of age. On follow-up call, one day after initial contact, the reporter indicated that the puppy was given supportive care but passed away 12 hours after the initial call. No additional 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