Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6358

2. Registrant Information.

Registrant Reference Number: PROSAR case #: 1-35154069

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-13

5. Location of incident.

Country: UNITED STATES

Prov / State: INDIANA

6. Date incident was first observed.

04-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)

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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 %

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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?

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

Unknown

6. Age (provide a range if necessary )

0.166

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

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Vomiting

• Cardiovascular System
  • Symptom - Tachycardia

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Shakiness

• Gastrointestinal System
  • Symptom - Bloody diarrhea

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

1-35154069 -The reporter, a pet owner, indicated that her 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 her 8-week-old, male mixed breed dog one day prior to initial contact with the registrant during the evening and later that same night the dog vomited multiple times. At the time of the initial call the reporter indicated that the dog had a rapid heart rate and was shaking. The reporter also stated that prior to applying this product the dog had not eaten for a couple of days. The reporter was advised that per package labeling the product is only meant to be applied to dogs that are greater than 12 weeks of age. The reporter was further advised that anorexia prior to product application may be an indication of underlying gastrointestinal illness that has now worsened. Parvovirus is always a concern in a young puppy that is not eating and vomiting. Tachycardia may be secondary to dehydration from vomiting and shaking can be seen with poor nutrition or a fever. On follow-up call, three days later, the reporter indicated that the puppy died one day after speaking with the registrant. Prior to death the puppy had bloody diarrhea and the reporter does suspect that the dog had parvovirus. Veterinary care was not sought due to limited finances. No further information is available.

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To be determined by Registrant

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

Death

19. Provide supplemental information here