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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6355

2. Registrant Information.

Registrant Reference Number: PROSAR case #: 1-35181866

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.

08-OCT-13

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

6. Date incident was first observed.

05-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 5-14 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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

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

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

  • General
    • Symptom - Pain
    • Symptom - Vocalizing
  • Nervous and Muscular Systems
    • Symptom - Shaking
    • Symptom - Ataxia
  • Gastrointestinal System
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Abnormal gait
    • Symptom - Fasciculations
    • Symptom - Recumbent
  • Gastrointestinal System
    • Symptom - Salivating excessively
  • General
    • Symptom - Abnormal behaviour
    • Specify - Sticking out its tongue
    • Symptom - Hypothermia
  • Blood
    • Symptom - Hyperglycemia
    • Symptom - Leukocytosis
  • Nervous and Muscular Systems
    • Symptom - Extensor rigidity
    • Symptom - Unresponsive
  • Gastrointestinal System
    • Symptom - Other
    • Specify - Mild Megaesophagus
  • 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?

Yes

14. b) How long was the animal hospitalized?

2

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

1-35181866- The reporter, a veterinarian, indicated that a dog was exposed to a spot-on product containing the active ingredients etofenprox, n-octyl bicycloheptene dicarboximide and piperonyl butoxide. The reporter indicated that the pet owner applied the product to their 4-year-old, 6 pound Yorkshire terrier four days prior to initial contact with the registrant. One day after product application the pet owner thought the dog was in pain because it was whining and shivering. The next day (two days after product application) the dog was walking sideways, vomiting, shaking, standing in a corner and wouldnt move. The dog presented to the clinic the following day (three days after product application) at that time it was rigid, twitching, laying on its side, its tongue was sticking out, it was drooling and depressed. Its temperature was low at 99 degrees Fahrenheit. Blood work showed mature neutrophilia with a count of 20,000 white blood cells/ul. The Blood Glucose was elevated at 186 mg/dL. The reporter treated the dog with Cerenia, injectable Baytril and then took the dog to her house for the night for monitoring. The next morning, the dog seemed better at first, but then began declining and at the time of the initial call the dog was in lateral recumbency with extensor rigidity, his tongue was hanging out and he was not aware of his surroundings. The reporter was advised that the described symptoms are not consistent with exposure to the product and additional diagnostics were recommended to determine an underlying cause and appropriate treatment. On follow-up call, one day later, a clinic employee indicated that the dog died last night. Per the clinic employee the dog had not been vaccinated for rabies so the head had been submitted for rabies testing at the Indiana State Board of Health. The body was sent to Kansas State for necropsy. On necropsy of the body mild megaesophagus was noted but no other significant gross or histopathological findings were identified. A cause of death could not be identified. Information on the rabies testing or any brain testing is not available. 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