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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-5630

2. Registrant Information.

Registrant Reference Number: ProPharma Group case:# 1-45394454

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.

28-AUG-16

5. Location of incident.

Country: UNITED STATES

Prov / State: ALABAMA

6. Date incident was first observed.

26-AUG-16

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. Unknown

Product Name: HARTZ ULTRAGUARD TOPICAL FLEA&TICK PREV. FOR DOGS&PUPPIES 61-150 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

German Shepherd

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

85

lbs

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

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Foaming at mouth
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Walking in circles
  • Respiratory System
    • Symptom - Difficulty Breathing
  • Nervous and Muscular Systems
    • Symptom - Bizarre behaviour
    • Symptom - Muscle tremors
    • Symptom - Seizure
    • Symptom - Shaking

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?

Unknown

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

1-45394454 - The reporter, a pet owner, indicated her dog was exposed to an insecticidal spot-on product containing the active ingredients etofenprox, N-octyl bicycloheptene dicarboximide, and piperonyl butoxide. Two days before the initial contact with the company, the reporter applied the product to her 85-pound, 3-year-old, male German Shepherd dog. Within six hours of application the reporter noticed the dog had trouble breathing. One day before initial contact, the reporter noticed the dog was shaking, walking in circles, and still had difficulty breathing. On the day of initial contact with the registrant, the reporter took the dog to a veterinary emergency clinic where the dog started having muscle tremors. The reporter was told this is not an expected reaction to the product, especially two days after application. The dog should be bathed and treated symptomatically. One day after initial contact with the registrant, the reporter indicated the dog had started having seizures and she was transferring the dog to another veterinary facility for more care. Four days after initial contact, the reporter indicated the dog had died at the veterinary hospital that morning. Condolences were offered to the reporter, and information for necropsy was forwarded to the reporters veterinary clinic. 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